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NCT01137682 · OUTCOME

Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated 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 normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect IGF-1 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 Extension33.3Not reported21.4047.06Not reported
Pasireotide LAR 60 mg Extension29.0Not reported17.9843.61Not reported
Cross Over to Pasireotide Extension25.8Not reported15.5338.50Not reported
Week 28
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension29.8Not reported18.4343.40Not reported
Pasireotide LAR 60 mg Extension33.3Not reported21.0947.47Not reported
Cross Over to Pasireotide Extension22.6Not reported12.9334.97Not reported
Week 40
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension36.8Not reported24.4550.66Not reported
Pasireotide LAR 60 mg Extension37.0Not reported24.2951.26Not reported
Cross Over to Pasireotide Extension24.2Not reported14.2236.74Not reported
Week 52
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension28.1Not reported16.9741.54Not reported
Pasireotide LAR 60 mg Extension33.3Not reported21.0947.47Not reported
Cross Over to Pasireotide Extension25.8Not reported15.5338.50Not reported
Week 64
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension33.3Not reported21.4047.06Not reported
Pasireotide LAR 60 mg Extension27.8Not reported16.4641.64Not reported
Cross Over to Pasireotide Extension29.0Not reported18.2041.95Not reported
Week 76
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension26.3Not reported15.5439.66Not reported
Pasireotide LAR 60 mg Extension35.2Not reported22.6849.38Not reported
Cross Over to Pasireotide Extension29.0Not reported18.2041.95Not reported
Week 88
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension28.1Not reported16.9741.54Not reported
Pasireotide LAR 60 mg Extension35.2Not reported22.6849.38Not reported
Cross Over to Pasireotide Extension25.8Not reported15.5338.50Not reported
Week 100
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension31.6Not reported19.9145.24Not reported
Pasireotide LAR 60 mg Extension29.6Not reported17.9843.61Not reported
Cross Over to Pasireotide Extension32.3Not reported20.9445.34Not reported
Week 112
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension31.6Not reported19.9145.24Not reported
Pasireotide LAR 60 mg Extension27.8Not reported16.4641.64Not reported
Cross Over to Pasireotide Extension30.6Not reported19.5643.65Not reported
Week 124
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension24.6Not reported14.1337.76Not reported
Pasireotide LAR 60 mg Extension31.5Not reported19.5245.55Not reported
Cross Over to Pasireotide Extension29.0Not reported18.2041.95Not reported
Week 136
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension21.1Not reported11.3833.89Not reported
Pasireotide LAR 60 mg Extension25.9Not reported14.9639.65Not reported
Cross Over to Pasireotide Extension37.1Not reported25.1650.31Not reported
Week 148
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension26.3Not reported15.5439.66Not reported
Pasireotide LAR 60 mg Extension22.2Not reported12.0435.60Not reported
Cross Over to Pasireotide Extension33.9Not reported22.3347.01Not reported
Week 160
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension24.6Not reported14.1337.76Not reported
Pasireotide LAR 60 mg Extension25.9Not reported14.9639.65Not reported
Cross Over to Pasireotide Extension33.9Not reported22.3347.01Not reported
Week 172
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension26.3Not reported15.5439.66Not reported
Pasireotide LAR 60 mg Extension22.2Not reported12.0435.60Not reported
Cross Over to Pasireotide Extension22.6Not reported12.9334.97Not reported
Week 184
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension19.3Not reported10.0531.91Not reported
Pasireotide LAR 60 mg Extension22.2Not reported12.0435.60Not reported
Cross Over to Pasireotide Extension22.6Not reported12.9334.97Not reported
Week 196
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension24.6Not reported14.1337.76Not reported
Pasireotide LAR 60 mg Extension22.2Not reported12.0435.60Not reported
Cross Over to Pasireotide Extension27.4Not reported16.8540.23Not reported
Week 208
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension22.8Not reported12.7435.84Not reported
Pasireotide LAR 60 mg Extension22.2Not reported12.0435.60Not reported
Cross Over to Pasireotide Extension21.0Not reported11.6633.18Not reported
Week 220
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension22.8Not reported12.7435.84Not reported
Pasireotide LAR 60 mg Extension11.1Not reported4.1922.63Not reported
Cross Over to Pasireotide Extension19.4Not reported10.4231.37Not reported
Week 232
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 Extension14.8Not reported6.6227.12Not reported
Cross Over to Pasireotide Extension17.7Not reported9.2029.53Not reported
Week 244
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 Extension9.3Not reported3.0820.30Not reported
Cross Over to Pasireotide Extension14.5Not reported6.8625.78Not 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 Extension7.4Not reported2.0617.89Not reported
Cross Over to Pasireotide Extension6.5Not reported1.7915.70Not reported
Week 268
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension5.3Not reported1.1014.62Not reported
Pasireotide LAR 60 mg Extension5.6Not reported1.1615.39Not 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
        21.40
        upper Limit
        47.06
        value
        33.3
      2. group Id
        OG001
        lower Limit
        17.98
        upper Limit
        43.61
        value
        29.0
      3. group Id
        OG002
        lower Limit
        15.53
        upper Limit
        38.50
        value
        25.8
    title
    Week 16
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.43
        upper Limit
        43.40
        value
        29.8
      2. group Id
        OG001
        lower Limit
        21.09
        upper Limit
        47.47
        value
        33.3
      3. group Id
        OG002
        lower Limit
        12.93
        upper Limit
        34.97
        value
        22.6
    title
    Week 28
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.45
        upper Limit
        50.66
        value
        36.8
      2. group Id
        OG001
        lower Limit
        24.29
        upper Limit
        51.26
        value
        37.0
      3. group Id
        OG002
        lower Limit
        14.22
        upper Limit
        36.74
        value
        24.2
    title
    Week 40
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.97
        upper Limit
        41.54
        value
        28.1
      2. group Id
        OG001
        lower Limit
        21.09
        upper Limit
        47.47
        value
        33.3
      3. group Id
        OG002
        lower Limit
        15.53
        upper Limit
        38.50
        value
        25.8
    title
    Week 52
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.40
        upper Limit
        47.06
        value
        33.3
      2. group Id
        OG001
        lower Limit
        16.46
        upper Limit
        41.64
        value
        27.8
      3. group Id
        OG002
        lower Limit
        18.20
        upper Limit
        41.95
        value
        29.0
    title
    Week 64
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.54
        upper Limit
        39.66
        value
        26.3
      2. group Id
        OG001
        lower Limit
        22.68
        upper Limit
        49.38
        value
        35.2
      3. group Id
        OG002
        lower Limit
        18.20
        upper Limit
        41.95
        value
        29.0
    title
    Week 76
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.97
        upper Limit
        41.54
        value
        28.1
      2. group Id
        OG001
        lower Limit
        22.68
        upper Limit
        49.38
        value
        35.2
      3. group Id
        OG002
        lower Limit
        15.53
        upper Limit
        38.50
        value
        25.8
    title
    Week 88
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.91
        upper Limit
        45.24
        value
        31.6
      2. group Id
        OG001
        lower Limit
        17.98
        upper Limit
        43.61
        value
        29.6
      3. group Id
        OG002
        lower Limit
        20.94
        upper Limit
        45.34
        value
        32.3
    title
    Week 100
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.91
        upper Limit
        45.24
        value
        31.6
      2. group Id
        OG001
        lower Limit
        16.46
        upper Limit
        41.64
        value
        27.8
      3. group Id
        OG002
        lower Limit
        19.56
        upper Limit
        43.65
        value
        30.6
    title
    Week 112
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.13
        upper Limit
        37.76
        value
        24.6
      2. group Id
        OG001
        lower Limit
        19.52
        upper Limit
        45.55
        value
        31.5
      3. group Id
        OG002
        lower Limit
        18.20
        upper Limit
        41.95
        value
        29.0
    title
    Week 124
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.38
        upper Limit
        33.89
        value
        21.1
      2. group Id
        OG001
        lower Limit
        14.96
        upper Limit
        39.65
        value
        25.9
      3. group Id
        OG002
        lower Limit
        25.16
        upper Limit
        50.31
        value
        37.1
    title
    Week 136
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.54
        upper Limit
        39.66
        value
        26.3
      2. group Id
        OG001
        lower Limit
        12.04
        upper Limit
        35.60
        value
        22.2
      3. group Id
        OG002
        lower Limit
        22.33
        upper Limit
        47.01
        value
        33.9
    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 normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect IGF-1 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 Participants With Normalization of Sex- and Age-adjusted IGF-1treated 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