NCT02354534 · OUTCOME

Number of Participants With Serious Adverse Events

Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3) · Source last updated 2021-04-28

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: 41 weeks

What was measured

Number of participants with serious adverse events or dose limiting toxicities related to the study intervention assessed using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.

Groups in this outcome

50 mg Artesunate Suppositories, 1 Cycle

Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories

200 mg Artesunate Suppositories, 1 Cycle

Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories

200 mg Artesunate Suppositories,2 Cycles

Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories

200 mg Artesunate Suppositories,3 Cycles

Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories

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
50 mg Artesunate Suppositories, 1 Cycle	3
200 mg Artesunate Suppositories, 1 Cycle	9
200 mg Artesunate Suppositories,2 Cycles	10
200 mg Artesunate Suppositories,3 Cycles	8

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
50 mg Artesunate Suppositories, 1 Cycle	Not reported	Not reported	Not reported	Not reported
200 mg Artesunate Suppositories, 1 Cycle	Not reported	Not reported	Not reported	Not reported
200 mg Artesunate Suppositories,2 Cycles	Not reported	Not reported	Not reported	Not reported
200 mg Artesunate Suppositories,3 Cycles	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
9
group Id
OG002
value
10
group Id
OG003
value
8
units
Participants

description

Number of participants with serious adverse events or dose limiting toxicities related to the study intervention assessed using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.

groups

description
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
id
OG000
title
50 mg Artesunate Suppositories, 1 Cycle
description
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
id
OG001
title
200 mg Artesunate Suppositories, 1 Cycle
description
Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
id
OG002
title
200 mg Artesunate Suppositories,2 Cycles
description
Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
id
OG003
title
200 mg Artesunate Suppositories,3 Cycles

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

41 weeks

title

Number of Participants With Serious Adverse Events

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice