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NCT01915303 · OUTCOME

LDL, HDL and Total Cholesterol at Week 35

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
MEAN
Unit
mmol/L
Interval / dispersion
Standard Deviation
Time frame
Baseline and week 35

What was measured

LDL=Low density lipoprotein, HDL=high density llipoprotein and total protein were analyzed by a central laboratory

Analysis population: Full analysis set

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

HDL Baseline

Analysis denominator · Participants

GroupSource count
All Patients68
Values in mmol/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Patients1.50.3Not reportedNot reportedNot reported
HDL Week 35 n=41

Analysis denominator · Participants

GroupSource count
All Patients41
Values in mmol/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Patients1.50.4Not reportedNot reportedNot reported
LDL Baseline

Analysis denominator · Participants

GroupSource count
All Patients68
Values in mmol/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Patients3.21.0Not reportedNot reportedNot reported
LDL Week 35 n=41

Analysis denominator · Participants

GroupSource count
All Patients41
Values in mmol/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Patients2.81.0Not reportedNot reportedNot reported
Total Baseline

Analysis denominator · Participants

GroupSource count
All Patients68
Values in mmol/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Patients69.43.7Not reportedNot reportedNot reported
Total Week 35 n=41

Analysis denominator · Participants

GroupSource count
All Patients41
Values in mmol/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Patients68.64.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.3
        value
        1.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      units
      Participants
    title
    HDL Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.4
        value
        1.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        41
      units
      Participants
    title
    HDL Week 35 n=41
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.0
        value
        3.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      units
      Participants
    title
    LDL Baseline
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.0
        value
        2.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        41
      units
      Participants
    title
    LDL Week 35 n=41
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.7
        value
        69.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      units
      Participants
    title
    Total Baseline
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.8
        value
        68.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        41
      units
      Participants
    title
    Total Week 35 n=41
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    units
    Participants
description
LDL=Low density lipoprotein, HDL=high density llipoprotein and total protein were analyzed by a central laboratory
dispersion Type
Standard Deviation
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
MEAN
population Description
Full analysis set
reporting Status
POSTED
time Frame
Baseline and week 35
title
LDL, HDL and Total Cholesterol at Week 35
type
SECONDARY
unit Of Measure
mmol/L

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

Preserved source evidence · Not medical advice