NCT03051516 · OUTCOME

Time to Recurrence of Anogenital High Grade Squamous Intraepithelial Lesion (HSIL)

HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions · Source last updated 2024-02-28

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

Measure: NUMBER
Unit: Recurrent events per 100 person-years
Interval / dispersion: Not reported
Time frame: Up to month 36

What was measured

Will compare vaccine and placebo recipients. Will evaluate differences in the hazard of recurrence using Cox proportional hazards in the intention to treat population and the per protocol population.

Groups in this outcome

Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)

Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM

Arm II (Placebo)

Patients receive placebo IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given IM Questionnaire Administration: Ancillary studies

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

Analysis denominator · Participants

Group	Source count
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)	91
Arm II (Placebo)	94

Reported measurements

Source class 1

Values in Recurrent events per 100 person-years · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)	8.1	Not reported	Not reported	Not reported	Not reported
Arm II (Placebo)	10.1	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.54
statistical Method
Log Rank

Complete source fields

analyses

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.54
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
value
8.1
group Id
OG001
value
10.1

denoms

counts
group Id
OG000
value
91
group Id
OG001
value
94
units
Participants

description

Will compare vaccine and placebo recipients. Will evaluate differences in the hazard of recurrence using Cox proportional hazards in the intention to treat population and the per protocol population.

groups

description
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
id
OG000
title
Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)
description
Patients receive placebo IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given IM Questionnaire Administration: Ancillary studies
id
OG001
title
Arm II (Placebo)

param Type

NUMBER

reporting Status

POSTED

time Frame

Up to month 36

title

Time to Recurrence of Anogenital High Grade Squamous Intraepithelial Lesion (HSIL)

type

SECONDARY

unit Of Measure

Recurrent events per 100 person-years

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

Preserved source evidence · Not medical advice