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NCT02354508 · OUTCOME

Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening

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

Percentage of participants achieving IGF-1 \<ULN at weeks 12, 24 \& 36.

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

GH: ≥1 - ≤ 2.5 μg/L

These Participants had this GH level at screening

GH: > 2.5 μg/L

These Participants had this GH level at screening

GH: Missing

These Participants were missing GH levels at screening

Pasireotide LAR Overall

This is the total sum of participants with at screening with various or missing GH levels

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

Analysis denominator · Participants

GroupSource count
GH: ≥1 - ≤ 2.5 μg/L28
GH: > 2.5 μg/L94
GH: Missing1
Pasireotide LAR Overall123

Reported measurements

Week 12
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
GH: ≥1 - ≤ 2.5 μg/L35.7Not reported18.6455.93Not reported
GH: > 2.5 μg/L16.0Not reported9.2224.95Not reported
GH: Missing0.0Not reported0.0097.50Not reported
Pasireotide LAR Overall20.3Not reported13.6128.52Not reported
Week 24
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
GH: ≥1 - ≤ 2.5 μg/L42.9Not reported24.4662.82Not reported
GH: > 2.5 μg/L23.4Not reported15.2933.26Not reported
GH: Missing0.0Not reported0.0097.50Not reported
Pasireotide LAR Overall27.6Not reported19.9636.43Not reported
Week 36
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
GH: ≥1 - ≤ 2.5 μg/L50.0Not reported30.6569.35Not reported
GH: > 2.5 μg/L25.5Not reported17.0935.57Not reported
GH: Missing0.0Not reported0.0097.50Not reported
Pasireotide LAR Overall30.9Not reported22.8839.86Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.64
        upper Limit
        55.93
        value
        35.7
      2. group Id
        OG001
        lower Limit
        9.22
        upper Limit
        24.95
        value
        16.0
      3. group Id
        OG002
        lower Limit
        0.00
        upper Limit
        97.50
        value
        0.0
      4. group Id
        OG003
        lower Limit
        13.61
        upper Limit
        28.52
        value
        20.3
    title
    Week 12
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.46
        upper Limit
        62.82
        value
        42.9
      2. group Id
        OG001
        lower Limit
        15.29
        upper Limit
        33.26
        value
        23.4
      3. group Id
        OG002
        lower Limit
        0.00
        upper Limit
        97.50
        value
        0.0
      4. group Id
        OG003
        lower Limit
        19.96
        upper Limit
        36.43
        value
        27.6
    title
    Week 24
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        30.65
        upper Limit
        69.35
        value
        50.0
      2. group Id
        OG001
        lower Limit
        17.09
        upper Limit
        35.57
        value
        25.5
      3. group Id
        OG002
        lower Limit
        0.00
        upper Limit
        97.50
        value
        0.0
      4. group Id
        OG003
        lower Limit
        22.88
        upper Limit
        39.86
        value
        30.9
    title
    Week 36
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      94
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      123
    units
    Participants
description
Percentage of participants achieving IGF-1 \<ULN at weeks 12, 24 \& 36.
dispersion Type
95% Confidence Interval
groups
  1. description
    These Participants had this GH level at screening
    id
    OG000
    title
    GH: ≥1 - ≤ 2.5 μg/L
  2. description
    These Participants had this GH level at screening
    id
    OG001
    title
    GH: > 2.5 μg/L
  3. description
    These Participants were missing GH levels at screening
    id
    OG002
    title
    GH: Missing
  4. description
    This is the total sum of participants with at screening with various or missing GH levels
    id
    OG003
    title
    Pasireotide LAR Overall
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 IGF-1 <ULN Overall by GH Level at Screening
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice