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NCT02354508 · OUTCOME

Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status

Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues · Source last updated 2019-12-10

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Weeks 12, 24 & 36

What was measured

Core phase - Percentage of patients achieving GH \<1μg/L at week 12, 24, 36 overall and by GH level at screening.

Analysis population: FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.

Groups in this outcome

Diabetic

Participants who were diabetic in the Pasireotide LAR overall group

Pre-diabetic

Participants who were pre-diabetic in the Pasireotide LAR overall group

Non-diabetic

Participants who were non-diabetic in the Pasireotide LAR overall group

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

Analysis denominator · Participants

GroupSource count
Diabetic52
Pre-diabetic60
Non-diabetic11

Reported measurements

Week 12
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Diabetic13.5Not reported5.5925.79Not reported
Pre-diabetic10.0Not reported3.7620.51Not reported
Non-diabetic0.0Not reported0.0028.49Not reported
Week 24
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Diabetic13.5Not reported5.5925.79Not reported
Pre-diabetic13.3Not reported5.9424.59Not reported
Non-diabetic9.1Not reported0.2341.28Not reported
Week 36
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Diabetic15.4Not reported6.8828.08Not reported
Pre-diabetic16.7Not reported8.2928.52Not reported
Non-diabetic0.0Not reported0.0028.49Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.59
        upper Limit
        25.79
        value
        13.5
      2. group Id
        OG001
        lower Limit
        3.76
        upper Limit
        20.51
        value
        10.0
      3. group Id
        OG002
        lower Limit
        0.00
        upper Limit
        28.49
        value
        0.0
    title
    Week 12
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.59
        upper Limit
        25.79
        value
        13.5
      2. group Id
        OG001
        lower Limit
        5.94
        upper Limit
        24.59
        value
        13.3
      3. group Id
        OG002
        lower Limit
        0.23
        upper Limit
        41.28
        value
        9.1
    title
    Week 24
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.88
        upper Limit
        28.08
        value
        15.4
      2. group Id
        OG001
        lower Limit
        8.29
        upper Limit
        28.52
        value
        16.7
      3. group Id
        OG002
        lower Limit
        0.00
        upper Limit
        28.49
        value
        0.0
    title
    Week 36
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    2. group Id
      OG001
      value
      60
    3. group Id
      OG002
      value
      11
    units
    Participants
description
Core phase - Percentage of patients achieving GH \<1μg/L at week 12, 24, 36 overall and by GH level at screening.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants who were diabetic in the Pasireotide LAR overall group
    id
    OG000
    title
    Diabetic
  2. description
    Participants who were pre-diabetic in the Pasireotide LAR overall group
    id
    OG001
    title
    Pre-diabetic
  3. description
    Participants who were non-diabetic in the Pasireotide LAR overall group
    id
    OG002
    title
    Non-diabetic
param Type
NUMBER
population Description
FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.
reporting Status
POSTED
time Frame
Weeks 12, 24 & 36
title
Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice