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NCT01047345 · OUTCOME

Percentage of Participants Who Experience an SAE- Extension Study

A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006) · Source last updated 2018-11-27

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
Not reported
Time frame
up to Month 7 - Extension Study

What was measured

An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.

Analysis population: All participants who received at least 1 vaccination in Extension Study and had available follow-up data.

Groups in this outcome

9vHPV Vaccine - Extension Study

Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.

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

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine - Extension Study99

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
9vHPV Vaccine - Extension Study2.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2.0
denoms
  1. counts
    1. group Id
      OG000
      value
      99
    units
    Participants
description
An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.
groups
  1. description
    Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
    id
    OG000
    title
    9vHPV Vaccine - Extension Study
param Type
NUMBER
population Description
All participants who received at least 1 vaccination in Extension Study and had available follow-up data.
reporting Status
POSTED
time Frame
up to Month 7 - Extension Study
title
Percentage of Participants Who Experience an SAE- Extension Study
type
OTHER_PRE_SPECIFIED
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice