NCT02804750 · OUTCOME

Percentage of Participants With One or More Adverse Events

Study to Evaluate CORT125134 in Participants With Cushing's Syndrome · Source last updated 2019-10-15

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: Group 1: up to Week 16; Group 2: up to Week 20

What was measured

All treatment-emergent adverse events were recorded and summarized.

Analysis population: All enrolled participants who received at least 1 dose of study drug

Groups in this outcome

Group 1: Low-dose Group

100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.

Group 2: High-dose Group

250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.

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
Group 1: Low-dose Group	17
Group 2: High-dose Group	18

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Group 1: Low-dose Group	15	Not reported	Not reported	Not reported	Not reported
Group 2: High-dose Group	18	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
15
group Id
OG001
value
18

denoms

counts
group Id
OG000
value
17
group Id
OG001
value
18
units
Participants

description

All treatment-emergent adverse events were recorded and summarized.

groups

description
100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
id
OG000
title
Group 1: Low-dose Group
description
250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.
id
OG001
title
Group 2: High-dose Group

param Type

COUNT_OF_PARTICIPANTS

population Description

All enrolled participants who received at least 1 dose of study drug

reporting Status

POSTED

time Frame

Group 1: up to Week 16; Group 2: up to Week 20

title

Percentage of Participants With One or More Adverse Events

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice