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NCT01915303 · OUTCOME

Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN

Study of the Efficacy and Safety of Pasireotide s.c. +/- Cabergoline in Patients With Cushing's Disease · Source last updated 2020-09-18

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

Measure
NUMBER
Unit
percentage of responders
Interval / dispersion
95% Confidence Interval
Time frame
Baseline up to week 235

What was measured

Actual mean value of mUFC at each scheduled visit was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit when UFC was measured.

Analysis population: Full analysis set. The data beyond Week 139 should be interpreted with caution given that small number of subjects were monitored

Groups in this outcome

All Patients

Pasireotide montherapy (0.6 mg bid to 0.9 mg bid) was administered until the biochemical control was achieved and if not achieved, a combination was administered: pasireotide (0.9 mg bid) + cabergoline (0.5 QD to 1 mg QD). Patients were able to add cabergoline at anytime during core and extension

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

Analysis denominator · Participants

GroupSource count
All Patients68

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
All Patients68
Values in percentage of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients4.4Not reported0.912.4Not reported
Core Week 17 n=57

Analysis denominator · Participants

GroupSource count
All Patients57
Values in percentage of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients28.1Not reported17.041.5Not reported
Core Week 35 n=45

Analysis denominator · Participants

GroupSource count
All Patients45
Values in percentage of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients48.9Not reported33.764.2Not reported
Ext Week 43 n=22

Analysis denominator · Participants

GroupSource count
All Patients22
Values in percentage of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients63.6Not reported40.782.8Not reported
Ext Week 67 n=17

Analysis denominator · Participants

GroupSource count
All Patients17
Values in percentage of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients47.1Not reported23.072.2Not reported
Ext Week 91 n=18

Analysis denominator · Participants

GroupSource count
All Patients18
Values in percentage of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients61.1Not reported35.782.7Not reported
Ext Week 115 n=13

Analysis denominator · Participants

GroupSource count
All Patients13
Values in percentage of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients76.9Not reported46.295.0Not reported
Ext Week 139 n=9

Analysis denominator · Participants

GroupSource count
All Patients9
Values in percentage of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients77.8Not reported40.097.2Not reported
Ext Week 163 n=6

Analysis denominator · Participants

GroupSource count
All Patients6
Values in percentage of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients66.7Not reported22.395.7Not reported
Ext Week 187 n=4

Analysis denominator · Participants

GroupSource count
All Patients4
Values in percentage of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients75.0Not reported19.499.4Not reported
Ext Week 211 n=3

Analysis denominator · Participants

GroupSource count
All Patients3
Values in percentage of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients66.7Not reported9.499.2Not reported
Ext Week 235 n=3

Analysis denominator · Participants

GroupSource count
All Patients3
Values in percentage of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients100Not reported29.2100.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.9
        upper Limit
        12.4
        value
        4.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.0
        upper Limit
        41.5
        value
        28.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      units
      Participants
    title
    Core Week 17 n=57
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.7
        upper Limit
        64.2
        value
        48.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    Core Week 35 n=45
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        40.7
        upper Limit
        82.8
        value
        63.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      units
      Participants
    title
    Ext Week 43 n=22
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23.0
        upper Limit
        72.2
        value
        47.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    Ext Week 67 n=17
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.7
        upper Limit
        82.7
        value
        61.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      units
      Participants
    title
    Ext Week 91 n=18
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        46.2
        upper Limit
        95.0
        value
        76.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Ext Week 115 n=13
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        40.0
        upper Limit
        97.2
        value
        77.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Ext Week 139 n=9
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.3
        upper Limit
        95.7
        value
        66.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Ext Week 163 n=6
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.4
        upper Limit
        99.4
        value
        75.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Ext Week 187 n=4
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.4
        upper Limit
        99.2
        value
        66.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Ext Week 211 n=3
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29.2
        upper Limit
        100.0
        value
        100
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Ext Week 235 n=3
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    units
    Participants
description
Actual mean value of mUFC at each scheduled visit was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit when UFC was measured.
dispersion Type
95% Confidence Interval
groups
  1. description
    Pasireotide montherapy (0.6 mg bid to 0.9 mg bid) was administered until the biochemical control was achieved and if not achieved, a combination was administered: pasireotide (0.9 mg bid) + cabergoline (0.5 QD to 1 mg QD). Patients were able to add cabergoline at anytime during core and extension
    id
    OG000
    title
    All Patients
param Type
NUMBER
population Description
Full analysis set. The data beyond Week 139 should be interpreted with caution given that small number of subjects were monitored
reporting Status
POSTED
time Frame
Baseline up to week 235
title
Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN
type
SECONDARY
unit Of Measure
percentage of responders

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

Preserved source evidence · Not medical advice