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NCT03697109 · OUTCOME

Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.

A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome · Source last updated 2025-07-16

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
OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase

Analysis population: The analysis population was patients in the Safety Population, which included all enrolled patients who received at least 1 dose of study drug.

Groups in this outcome

Relacorilant (OL Phase)

Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.

Relacorilant (RW Phase)

Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.

Placebo (RW Phase)

Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug. Placebo: Placebo matched to study drug

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

Analysis denominator · Participants

GroupSource count
Relacorilant (OL Phase)152
Relacorilant (RW Phase)30
Placebo (RW Phase)32

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Relacorilant (OL Phase)147Not reportedNot reportedNot reportedNot reported
Relacorilant (RW Phase)23Not reportedNot reportedNot reportedNot reported
Placebo (RW Phase)27Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        147
      2. group Id
        OG001
        value
        23
      3. group Id
        OG002
        value
        27
denoms
  1. counts
    1. group Id
      OG000
      value
      152
    2. group Id
      OG001
      value
      30
    3. group Id
      OG002
      value
      32
    units
    Participants
groups
  1. description
    Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.
    id
    OG000
    title
    Relacorilant (OL Phase)
  2. description
    Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.
    id
    OG001
    title
    Relacorilant (RW Phase)
  3. description
    Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug. Placebo: Placebo matched to study drug
    id
    OG002
    title
    Placebo (RW Phase)
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis population was patients in the Safety Population, which included all enrolled patients who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase
title
Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0.
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice