NCT02150213 · OUTCOME

Incidence of Uterine Endometrial Stromal Sarcomas

Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492 · Source last updated 2016-12-05

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

Measure: NUMBER
Unit: Participants
Interval / dispersion: Not reported
Time frame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212

What was measured

Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)

Analysis population: Full Analysis Set (FAS):included all patients who signed informed consent to enter the study, but this assessment was only done on female patients. Of the 31 female patients, two had a hysterectomy and were not evaluated (N=29)

Groups in this outcome

BGG492

This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to \> 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day

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
BGG492	29

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
BGG492	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0

denoms

counts
group Id
OG000
value
29
units
Participants

description

Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)

groups

description
This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to \> 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
id
OG000
title
BGG492

param Type

NUMBER

population Description

Full Analysis Set (FAS):included all patients who signed informed consent to enter the study, but this assessment was only done on female patients. Of the 31 female patients, two had a hysterectomy and were not evaluated (N=29)

reporting Status

POSTED

time Frame

Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212

title

Incidence of Uterine Endometrial Stromal Sarcomas

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice