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NCT01137682 · OUTCOME

Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)

Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly · Source last updated 2018-04-05

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
Extension baseline up to approximately week 268

What was measured

The percentage of patients achieving mean growth hormone (GH) levels \< 1.0 μg/L was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Concomitant medication known to affect GH levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set)

Groups in this outcome

Pasireotide LAR 40 mg Extension

If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg

Pasireotide LAR 60 mg Extension

If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg

Cross Over to Pasireotide Extension

Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.

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 40 mg Extension57
Pasireotide LAR 60 mg Extension54
Cross Over to Pasireotide Extension62

Reported measurements

Week 16
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension14.0Not reported6.2625.79Not reported
Pasireotide LAR 60 mg Extension27.8Not reported16.4641.64Not reported
Cross Over to Pasireotide Extension8.1Not reported2.6717.83Not reported
Week 28
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension14.0Not reported6.2625.79Not reported
Pasireotide LAR 60 mg Extension22.2Not reported12.0435.60Not reported
Cross Over to Pasireotide Extension9.7Not reported3.6319.88Not reported
Week 40
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension14.0Not reported6.2625.79Not reported
Pasireotide LAR 60 mg Extension13.0Not reported5.3724.90Not reported
Cross Over to Pasireotide Extension4.8Not reported1.0113.50Not reported
Week 52
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension12.3Not reported5.0823.68Not reported
Pasireotide LAR 60 mg Extension22.2Not reported12.0435.60Not reported
Cross Over to Pasireotide Extension9.7Not reported3.6319.88Not reported
Week 64
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension15.8Not reported7.4827.87Not reported
Pasireotide LAR 60 mg Extension18.5Not reported9.2531.43Not reported
Cross Over to Pasireotide Extension11.3Not reported4.6621.89Not reported
Week 76
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension12.3Not reported5.0823.68Not reported
Pasireotide LAR 60 mg Extension22.2Not reported12.0435.60Not reported
Cross Over to Pasireotide Extension11.3Not reported4.6621.89Not reported
Week 88
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension15.8Not reported7.4827.87Not reported
Pasireotide LAR 60 mg Extension22.2Not reported12.0435.60Not reported
Cross Over to Pasireotide Extension11.3Not reported4.6621.89Not reported
Week 100
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension17.5Not reported8.7529.91Not reported
Pasireotide LAR 60 mg Extension20.4Not reported10.6333.53Not reported
Cross Over to Pasireotide Extension17.7Not reported9.2029.53Not reported
Week 112
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension17.5Not reported8.7529.91Not reported
Pasireotide LAR 60 mg Extension25.9Not reported14.9639.65Not reported
Cross Over to Pasireotide Extension16.1Not reported8.0227.67Not reported
Week 124
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension12.3Not reported5.0823.68Not reported
Pasireotide LAR 60 mg Extension16.7Not reported7.9229.29Not reported
Cross Over to Pasireotide Extension14.5Not reported6.8625.78Not reported
Week 136
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension8.8Not reported2.9119.30Not reported
Pasireotide LAR 60 mg Extension25.9Not reported14.9639.65Not reported
Cross Over to Pasireotide Extension14.5Not reported6.8625.78Not reported
Week 148
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension14.0Not reported6.2625.79Not reported
Pasireotide LAR 60 mg Extension16.7Not reported7.9229.29Not reported
Cross Over to Pasireotide Extension14.5Not reported6.8625.78Not reported
Week 160
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension17.5Not reported8.7529.91Not reported
Pasireotide LAR 60 mg Extension18.5Not reported9.2531.43Not reported
Cross Over to Pasireotide Extension14.5Not reported6.8625.78Not reported
Week 172
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension17.5Not reported8.7529.91Not reported
Pasireotide LAR 60 mg Extension14.8Not reported6.6227.12Not reported
Cross Over to Pasireotide Extension14.5Not reported6.8625.78Not reported
Week 184
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension17.5Not reported8.7529.91Not reported
Pasireotide LAR 60 mg Extension18.5Not reported9.2531.43Not reported
Cross Over to Pasireotide Extension6.5Not reported1.7915.70Not reported
Week 196
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension15.8Not reported7.4827.87Not reported
Pasireotide LAR 60 mg Extension13.0Not reported5.3724.90Not reported
Cross Over to Pasireotide Extension12.9Not reported5.7423.85Not reported
Week 208
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension17.5Not reported8.7529.91Not reported
Pasireotide LAR 60 mg Extension13.0Not reported5.3724.90Not reported
Cross Over to Pasireotide Extension9.7Not reported3.6319.88Not reported
Week 220
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension15.8Not reported7.4827.87Not reported
Pasireotide LAR 60 mg Extension11.1Not reported4.1922.63Not reported
Cross Over to Pasireotide Extension9.7Not reported3.6319.88Not reported
Week 232
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension15.8Not reported7.4827.87Not reported
Pasireotide LAR 60 mg Extension3.7Not reported0.4512.75Not reported
Cross Over to Pasireotide Extension8.1Not reported2.6717.83Not reported
Week 244
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension12.3Not reported5.0823.68Not reported
Pasireotide LAR 60 mg Extension5.6Not reported1.1615.39Not reported
Cross Over to Pasireotide Extension8.1Not reported2.6717.83Not reported
Week 256
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension12.3Not reported5.0823.68Not reported
Pasireotide LAR 60 mg Extension3.7Not reported0.4512.75Not reported
Cross Over to Pasireotide Extension4.8Not reported1.0113.50Not reported
Week 268
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension3.5Not reported0.4312.11Not reported
Pasireotide LAR 60 mg Extension3.7Not reported0.4512.75Not reported
Cross Over to Pasireotide Extension1.6Not reported0.048.66Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.26
        upper Limit
        25.79
        value
        14.0
      2. group Id
        OG001
        lower Limit
        16.46
        upper Limit
        41.64
        value
        27.8
      3. group Id
        OG002
        lower Limit
        2.67
        upper Limit
        17.83
        value
        8.1
    title
    Week 16
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.26
        upper Limit
        25.79
        value
        14.0
      2. group Id
        OG001
        lower Limit
        12.04
        upper Limit
        35.60
        value
        22.2
      3. group Id
        OG002
        lower Limit
        3.63
        upper Limit
        19.88
        value
        9.7
    title
    Week 28
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.26
        upper Limit
        25.79
        value
        14.0
      2. group Id
        OG001
        lower Limit
        5.37
        upper Limit
        24.90
        value
        13.0
      3. group Id
        OG002
        lower Limit
        1.01
        upper Limit
        13.50
        value
        4.8
    title
    Week 40
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.08
        upper Limit
        23.68
        value
        12.3
      2. group Id
        OG001
        lower Limit
        12.04
        upper Limit
        35.60
        value
        22.2
      3. group Id
        OG002
        lower Limit
        3.63
        upper Limit
        19.88
        value
        9.7
    title
    Week 52
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.48
        upper Limit
        27.87
        value
        15.8
      2. group Id
        OG001
        lower Limit
        9.25
        upper Limit
        31.43
        value
        18.5
      3. group Id
        OG002
        lower Limit
        4.66
        upper Limit
        21.89
        value
        11.3
    title
    Week 64
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.08
        upper Limit
        23.68
        value
        12.3
      2. group Id
        OG001
        lower Limit
        12.04
        upper Limit
        35.60
        value
        22.2
      3. group Id
        OG002
        lower Limit
        4.66
        upper Limit
        21.89
        value
        11.3
    title
    Week 76
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.48
        upper Limit
        27.87
        value
        15.8
      2. group Id
        OG001
        lower Limit
        12.04
        upper Limit
        35.60
        value
        22.2
      3. group Id
        OG002
        lower Limit
        4.66
        upper Limit
        21.89
        value
        11.3
    title
    Week 88
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.75
        upper Limit
        29.91
        value
        17.5
      2. group Id
        OG001
        lower Limit
        10.63
        upper Limit
        33.53
        value
        20.4
      3. group Id
        OG002
        lower Limit
        9.20
        upper Limit
        29.53
        value
        17.7
    title
    Week 100
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.75
        upper Limit
        29.91
        value
        17.5
      2. group Id
        OG001
        lower Limit
        14.96
        upper Limit
        39.65
        value
        25.9
      3. group Id
        OG002
        lower Limit
        8.02
        upper Limit
        27.67
        value
        16.1
    title
    Week 112
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.08
        upper Limit
        23.68
        value
        12.3
      2. group Id
        OG001
        lower Limit
        7.92
        upper Limit
        29.29
        value
        16.7
      3. group Id
        OG002
        lower Limit
        6.86
        upper Limit
        25.78
        value
        14.5
    title
    Week 124
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.91
        upper Limit
        19.30
        value
        8.8
      2. group Id
        OG001
        lower Limit
        14.96
        upper Limit
        39.65
        value
        25.9
      3. group Id
        OG002
        lower Limit
        6.86
        upper Limit
        25.78
        value
        14.5
    title
    Week 136
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.26
        upper Limit
        25.79
        value
        14.0
      2. group Id
        OG001
        lower Limit
        7.92
        upper Limit
        29.29
        value
        16.7
      3. group Id
        OG002
        lower Limit
        6.86
        upper Limit
        25.78
        value
        14.5
    title
    Week 148
denoms
  1. counts
    1. group Id
      OG000
      value
      57
    2. group Id
      OG001
      value
      54
    3. group Id
      OG002
      value
      62
    units
    Participants
description
The percentage of patients achieving mean growth hormone (GH) levels \< 1.0 μg/L was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Concomitant medication known to affect GH levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set)
dispersion Type
95% Confidence Interval
groups
  1. description
    If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
    id
    OG000
    title
    Pasireotide LAR 40 mg Extension
  2. description
    If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
    id
    OG001
    title
    Pasireotide LAR 60 mg Extension
  3. description
    Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.
    id
    OG002
    title
    Cross Over to Pasireotide Extension
param Type
NUMBER
reporting Status
POSTED
time Frame
Extension baseline up to approximately week 268
title
Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice