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NCT02354508 · OUTCOME

Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN

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
Week 12, Week 24, Week 36

What was measured

Percentage of participants achieving GH \<1 μg/L and IGF-1 \<ULN at weeks 12 and 24 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

Pasireotide LAR (run-in Phase)

Participants who were part of the run-in phase, i.e. group 1)

Pasireotide LAR Overall

This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.

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

Analysis denominator · Participants

GroupSource count
Pasireotide LAR (run-in Phase)17
Pasireotide LAR Overall123

Reported measurements

Week 12: GH: ≥ 1 - ≤ 2.5 μg/L @ screening

Analysis denominator · Participants

GroupSource count
Pasireotide LAR (run-in Phase)4
Pasireotide LAR Overall28
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR (run-in Phase)25.0Not reported0.6380.59Not reported
Pasireotide LAR Overall28.6Not reported13.2248.67Not reported
Week 24: GH: ≥ 1 - ≤ 2.5 μg/L @ screening

Analysis denominator · Participants

GroupSource count
Pasireotide LAR (run-in Phase)4
Pasireotide LAR Overall28
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR (run-in Phase)25.0Not reported0.6380.59Not reported
Pasireotide LAR Overall39.3Not reported21.5059.42Not reported
Week 36: GH: ≥ 1 - ≤ 2.5 μg/L @ screening

Analysis denominator · Participants

GroupSource count
Pasireotide LAR (run-in Phase)4
Pasireotide LAR Overall28
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR (run-in Phase)25.0Not reported0.6380.59Not reported
Pasireotide LAR Overall42.9Not reported24.4662.82Not reported
Week 12: GH: > 2.5 μg/L @ screening

Analysis denominator · Participants

GroupSource count
Pasireotide LAR (run-in Phase)13
Pasireotide LAR Overall94
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR (run-in Phase)7.7Not reported0.1936.03Not reported
Pasireotide LAR Overall5.3Not reported1.7511.98Not reported
Week 24: GH: > 2.5 μg/L @ screening

Analysis denominator · Participants

GroupSource count
Pasireotide LAR (run-in Phase)13
Pasireotide LAR Overall94
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR (run-in Phase)7.7Not reported0.1936.03Not reported
Pasireotide LAR Overall5.3Not reported1.7511.98Not reported
Week 36: GH: > 2.5 μg/L @ screening

Analysis denominator · Participants

GroupSource count
Pasireotide LAR (run-in Phase)13
Pasireotide LAR Overall94
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR (run-in Phase)7.7Not reported0.1936.03Not reported
Pasireotide LAR Overall6.4Not reported2.3813.38Not reported
Week 12: GH: Missing

Analysis denominator · Participants

GroupSource count
Pasireotide LAR (run-in Phase)0
Pasireotide LAR Overall1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall0.0Not reported0.0097.50Not reported
Week 24: GH: Missing

Analysis denominator · Participants

GroupSource count
Pasireotide LAR (run-in Phase)0
Pasireotide LAR Overall1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall0.0Not reported0.0097.50Not reported
Week 36: GH: Missing

Analysis denominator · Participants

GroupSource count
Pasireotide LAR (run-in Phase)0
Pasireotide LAR Overall1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall0.0Not reported0.0097.50Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.63
        upper Limit
        80.59
        value
        25.0
      2. group Id
        OG001
        lower Limit
        13.22
        upper Limit
        48.67
        value
        28.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        28
      units
      Participants
    title
    Week 12: GH: ≥ 1 - ≤ 2.5 μg/L @ screening
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.63
        upper Limit
        80.59
        value
        25.0
      2. group Id
        OG001
        lower Limit
        21.50
        upper Limit
        59.42
        value
        39.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        28
      units
      Participants
    title
    Week 24: GH: ≥ 1 - ≤ 2.5 μg/L @ screening
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.63
        upper Limit
        80.59
        value
        25.0
      2. group Id
        OG001
        lower Limit
        24.46
        upper Limit
        62.82
        value
        42.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        28
      units
      Participants
    title
    Week 36: GH: ≥ 1 - ≤ 2.5 μg/L @ screening
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.19
        upper Limit
        36.03
        value
        7.7
      2. group Id
        OG001
        lower Limit
        1.75
        upper Limit
        11.98
        value
        5.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        94
      units
      Participants
    title
    Week 12: GH: > 2.5 μg/L @ screening
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.19
        upper Limit
        36.03
        value
        7.7
      2. group Id
        OG001
        lower Limit
        1.75
        upper Limit
        11.98
        value
        5.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        94
      units
      Participants
    title
    Week 24: GH: > 2.5 μg/L @ screening
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.19
        upper Limit
        36.03
        value
        7.7
      2. group Id
        OG001
        lower Limit
        2.38
        upper Limit
        13.38
        value
        6.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        94
      units
      Participants
    title
    Week 36: GH: > 2.5 μg/L @ screening
  7. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        97.50
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Week 12: GH: Missing
  8. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        97.50
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Week 24: GH: Missing
  9. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        97.50
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Week 36: GH: Missing
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      123
    units
    Participants
description
Percentage of participants achieving GH \<1 μg/L and IGF-1 \<ULN at weeks 12 and 24 overall and by GH level at screening.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants who were part of the run-in phase, i.e. group 1)
    id
    OG000
    title
    Pasireotide LAR (run-in Phase)
  2. description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
    id
    OG001
    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
Week 12, Week 24, Week 36
title
Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice