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NCT02804750 · OUTCOME

Percentage of Participants With One or More Severe (≥Grade 3) 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 with Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (severe) 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

GroupSource count
Group 1: Low-dose Group17
Group 2: High-dose Group18

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 1: Low-dose Group3Not reportedNot reportedNot reportedNot reported
Group 2: High-dose Group7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        7
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      18
    units
    Participants
description
All treatment-emergent adverse events with Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (severe) were recorded and summarized.
groups
  1. 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
  2. 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 Severe (≥Grade 3) Adverse Events
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice