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NCT02354508 · OUTCOME

Extension Phase: Percentage of Participants With Mean GH < 1 μg/L at Weeks 48, 60, 72 and Overall, Pasireotide Montherapy and Pasireotide With Concomittant Medication and 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 48, 60, 72

What was measured

Percentage of patients achieving GH \<1 μg/L and IGF-1 \<ULN at week 48 by treatment with pasireotide LAR alone or with concomitant medications used to treat acromegaly

Analysis population: Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.

Groups in this outcome

Pasireotide LAR Monotherapy

These Participants were treated with pasireotide LAR only in the extension phase

Pasireotide With Concomitant Mediaction

These Participants were treated with pasireotide LAR as well as other concomitant medications in the extension phase

Pasireotide LAR Overall

This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

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 Monotherapy76
Pasireotide With Concomitant Mediaction12
Pasireotide LAR Overall88

Reported measurements

Wk48:GH: >= 1 - <= 2.5 μg/L at screen.

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Monotherapy17
Pasireotide With Concomitant Mediaction3
Pasireotide LAR Overall20
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Monotherapy76.5Not reported50.1093.19Not reported
Pasireotide With Concomitant Mediaction0.0Not reported0.0070.76Not reported
Pasireotide LAR Overall65.0Not reported40.7884.61Not reported
Wk60:GH: >= 1 - <= 2.5 μg/L at screen.

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Monotherapy17
Pasireotide With Concomitant Mediaction3
Pasireotide LAR Overall20
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Monotherapy70.6Not reported44.0489.69Not reported
Pasireotide With Concomitant Mediaction0.0Not reported0.0070.76Not reported
Pasireotide LAR Overall60.0Not reported36.0580.88Not reported
Wk72:GH: >= 1 - <= 2.5 μg/L at screen.

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Monotherapy17
Pasireotide With Concomitant Mediaction3
Pasireotide LAR Overall20
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Monotherapy64.7Not reported38.3385.79Not reported
Pasireotide With Concomitant Mediaction0.0Not reported0.0070.76Not reported
Pasireotide LAR Overall55.0Not reported31.5376.94Not reported
Wk48: GH: > 2.5 μg/L at screening

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Monotherapy59
Pasireotide With Concomitant Mediaction9
Pasireotide LAR Overall68
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Monotherapy11.9Not reported4.9122.93Not reported
Pasireotide With Concomitant Mediaction11.1Not reported0.2848.25Not reported
Pasireotide LAR Overall11.8Not reported5.2221.87Not reported
Wk60: GH: > 2.5 μg/L at screening

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Monotherapy59
Pasireotide With Concomitant Mediaction9
Pasireotide LAR Overall68
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Monotherapy11.9Not reported4.9122.93Not reported
Pasireotide With Concomitant Mediaction0.0Not reported0.0033.63Not reported
Pasireotide LAR Overall10.3Not reported4.2420.07Not reported
Wk72: GH: > 2.5 μg/L at screening

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Monotherapy59
Pasireotide With Concomitant Mediaction9
Pasireotide LAR Overall68
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Monotherapy11.9Not reported4.9122.93Not reported
Pasireotide With Concomitant Mediaction0.0Not reported0.0033.63Not reported
Pasireotide LAR Overall10.3Not reported4.2420.07Not reported
Week 48: Pasireotide LAR overall

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Monotherapy76
Pasireotide With Concomitant Mediaction12
Pasireotide LAR Overall88
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Monotherapy26.3Not reported16.8737.68Not reported
Pasireotide With Concomitant Mediaction8.3Not reported0.2138.48Not reported
Pasireotide LAR Overall23.9Not reported15.4234.14Not reported
Week 60: Pasireotide LAR overall

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Monotherapy76
Pasireotide With Concomitant Mediaction12
Pasireotide LAR Overall88
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Monotherapy25.0Not reported15.7736.26Not reported
Pasireotide With Concomitant Mediaction0.0Not reported0.0026.46Not reported
Pasireotide LAR Overall21.6Not reported13.5331.65Not reported
Week 72: Pasireotide LAR overall

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Monotherapy76
Pasireotide With Concomitant Mediaction12
Pasireotide LAR Overall88
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Monotherapy23.7Not reported14.6834.82Not reported
Pasireotide With Concomitant Mediaction0.0Not reported0.0026.46Not reported
Pasireotide LAR Overall20.5Not reported12.6030.39Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        50.10
        upper Limit
        93.19
        value
        76.5
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        70.76
        value
        0.0
      3. group Id
        OG002
        lower Limit
        40.78
        upper Limit
        84.61
        value
        65.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        20
      units
      Participants
    title
    Wk48:GH: >= 1 - <= 2.5 μg/L at screen.
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        44.04
        upper Limit
        89.69
        value
        70.6
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        70.76
        value
        0.0
      3. group Id
        OG002
        lower Limit
        36.05
        upper Limit
        80.88
        value
        60.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        20
      units
      Participants
    title
    Wk60:GH: >= 1 - <= 2.5 μg/L at screen.
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38.33
        upper Limit
        85.79
        value
        64.7
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        70.76
        value
        0.0
      3. group Id
        OG002
        lower Limit
        31.53
        upper Limit
        76.94
        value
        55.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        20
      units
      Participants
    title
    Wk72:GH: >= 1 - <= 2.5 μg/L at screen.
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.91
        upper Limit
        22.93
        value
        11.9
      2. group Id
        OG001
        lower Limit
        0.28
        upper Limit
        48.25
        value
        11.1
      3. group Id
        OG002
        lower Limit
        5.22
        upper Limit
        21.87
        value
        11.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        68
      units
      Participants
    title
    Wk48: GH: > 2.5 μg/L at screening
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.91
        upper Limit
        22.93
        value
        11.9
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        33.63
        value
        0.0
      3. group Id
        OG002
        lower Limit
        4.24
        upper Limit
        20.07
        value
        10.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        68
      units
      Participants
    title
    Wk60: GH: > 2.5 μg/L at screening
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.91
        upper Limit
        22.93
        value
        11.9
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        33.63
        value
        0.0
      3. group Id
        OG002
        lower Limit
        4.24
        upper Limit
        20.07
        value
        10.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        68
      units
      Participants
    title
    Wk72: GH: > 2.5 μg/L at screening
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.87
        upper Limit
        37.68
        value
        26.3
      2. group Id
        OG001
        lower Limit
        0.21
        upper Limit
        38.48
        value
        8.3
      3. group Id
        OG002
        lower Limit
        15.42
        upper Limit
        34.14
        value
        23.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        88
      units
      Participants
    title
    Week 48: Pasireotide LAR overall
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.77
        upper Limit
        36.26
        value
        25.0
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        26.46
        value
        0.0
      3. group Id
        OG002
        lower Limit
        13.53
        upper Limit
        31.65
        value
        21.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        88
      units
      Participants
    title
    Week 60: Pasireotide LAR overall
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.68
        upper Limit
        34.82
        value
        23.7
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        26.46
        value
        0.0
      3. group Id
        OG002
        lower Limit
        12.60
        upper Limit
        30.39
        value
        20.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        88
      units
      Participants
    title
    Week 72: Pasireotide LAR overall
denoms
  1. counts
    1. group Id
      OG000
      value
      76
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      88
    units
    Participants
description
Percentage of patients achieving GH \<1 μg/L and IGF-1 \<ULN at week 48 by treatment with pasireotide LAR alone or with concomitant medications used to treat acromegaly
dispersion Type
95% Confidence Interval
groups
  1. description
    These Participants were treated with pasireotide LAR only in the extension phase
    id
    OG000
    title
    Pasireotide LAR Monotherapy
  2. description
    These Participants were treated with pasireotide LAR as well as other concomitant medications in the extension phase
    id
    OG001
    title
    Pasireotide With Concomitant Mediaction
  3. description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
    id
    OG002
    title
    Pasireotide LAR Overall
param Type
NUMBER
population Description
Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.
reporting Status
POSTED
time Frame
Weeks 48, 60, 72
title
Extension Phase: Percentage of Participants With Mean GH < 1 μg/L at Weeks 48, 60, 72 and Overall, Pasireotide Montherapy and Pasireotide With Concomittant Medication and by GH Level at Screening
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice