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NCT01137682 · OUTCOME

Percentage of Patients With Mean GH < 2.5 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 \< 2.5 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)

Analysis population: Full analysis set (FAS): comprised all patients who were randomized. Following the intent-to-treat principle, patients were analyzed according to the study drug they were assigned to at randomization and actual stratum.

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

Control Arm (Octreotide or Lanreotide) 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
Control Arm (Octreotide or Lanreotide) Extension62

Reported measurements

Week 16
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension38.6Not reported26.0052.43Not reported
Pasireotide LAR 60 mg Extension55.6Not reported41.4069.08Not reported
Control Arm (Octreotide or Lanreotide) Extension33.9Not reported22.3347.01Not reported
Week 28
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension40.4Not reported27.5654.18Not reported
Pasireotide LAR 60 mg Extension44.4Not reported30.9258.60Not reported
Control Arm (Octreotide or Lanreotide) Extension43.5Not reported30.9956.74Not reported
Week 40
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension38.6Not reported26.0052.43Not reported
Pasireotide LAR 60 mg Extension42.6Not reported29.2356.79Not reported
Control Arm (Octreotide or Lanreotide) Extension40.3Not reported28.0553.55Not reported
Week 52
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension38.6Not reported26.0052.43Not reported
Pasireotide LAR 60 mg Extension46.3Not reported32.6260.39Not reported
Control Arm (Octreotide or Lanreotide) Extension41.9Not reported29.5155.15Not reported
Week 64
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension40.4Not reported27.5654.18Not reported
Pasireotide LAR 60 mg Extension37.0Not reported24.2951.26Not reported
Control Arm (Octreotide or Lanreotide) Extension41.9Not reported29.5155.15Not reported
Week 76
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 Extension44.4Not reported30.9258.60Not reported
Control Arm (Octreotide or Lanreotide) Extension45.2Not reported32.4858.32Not reported
Week 88
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension40.4Not reported27.5654.18Not reported
Pasireotide LAR 60 mg Extension42.6Not reported29.2356.79Not reported
Control Arm (Octreotide or Lanreotide) Extension45.2Not reported32.4858.32Not reported
Week 100
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension40.4Not reported27.5654.18Not reported
Pasireotide LAR 60 mg Extension40.7Not reported27.5754.97Not reported
Control Arm (Octreotide or Lanreotide) Extension46.8Not reported33.9859.88Not reported
Week 112
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 Extension44.4Not reported30.9258.60Not reported
Control Arm (Octreotide or Lanreotide) Extension40.3Not reported28.0553.55Not reported
Week 124
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension40.4Not reported27.5654.18Not reported
Pasireotide LAR 60 mg Extension31.5Not reported19.5245.55Not reported
Control Arm (Octreotide or Lanreotide) Extension41.9Not reported29.5155.15Not reported
Week 136
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 Extension35.2Not reported22.6849.38Not reported
Control Arm (Octreotide or Lanreotide) Extension43.5Not reported30.9956.74Not reported
Week 148
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension40.4Not reported27.5654.18Not reported
Pasireotide LAR 60 mg Extension33.3Not reported21.0947.47Not reported
Control Arm (Octreotide or Lanreotide) Extension43.5Not reported30.9956.74Not reported
Week 160
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension38.6Not reported26.0052.43Not reported
Pasireotide LAR 60 mg Extension33.3Not reported21.0947.47Not reported
Control Arm (Octreotide or Lanreotide) Extension40.3Not reported28.0553.55Not reported
Week 172
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension40.4Not reported27.5654.18Not reported
Pasireotide LAR 60 mg Extension37.0Not reported24.2951.26Not reported
Control Arm (Octreotide or Lanreotide) Extension38.7Not reported26.6051.93Not reported
Week 184
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 Extension31.5Not reported19.5245.55Not reported
Control Arm (Octreotide or Lanreotide) Extension33.9Not reported22.3347.01Not reported
Week 196
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 Extension29.6Not reported17.9843.61Not reported
Control Arm (Octreotide or Lanreotide) Extension35.5Not reported23.7448.66Not reported
Week 208
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 Extension24.1Not reported13.4937.64Not reported
Control Arm (Octreotide or Lanreotide) Extension25.8Not reported15.5338.50Not reported
Week 220
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 Extension18.5Not reported9.2531.43Not reported
Control Arm (Octreotide or Lanreotide) Extension22.6Not reported12.9334.97Not reported
Week 232
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension24.6Not reported14.337.76Not reported
Pasireotide LAR 60 mg Extension18.5Not reported9.2531.43Not reported
Control Arm (Octreotide or Lanreotide) Extension21.0Not reported11.6633.18Not reported
Week 244
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 Extension11.1Not reported4.1922.63Not reported
Control Arm (Octreotide or Lanreotide) Extension12.9Not reported5.7423.85Not reported
Week 256
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 Extension9.3Not reported3.0820.30Not reported
Control Arm (Octreotide or Lanreotide) Extension6.5Not reported1.7915.70Not reported
Week 268
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 40 mg Extension7.0Not reported1.9517.00Not reported
Pasireotide LAR 60 mg Extension5.6Not reported1.1615.39Not reported
Control Arm (Octreotide or Lanreotide) Extension3.2Not reported0.3911.17Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        26.00
        upper Limit
        52.43
        value
        38.6
      2. group Id
        OG001
        lower Limit
        41.40
        upper Limit
        69.08
        value
        55.6
      3. group Id
        OG002
        lower Limit
        22.33
        upper Limit
        47.01
        value
        33.9
    title
    Week 16
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.56
        upper Limit
        54.18
        value
        40.4
      2. group Id
        OG001
        lower Limit
        30.92
        upper Limit
        58.60
        value
        44.4
      3. group Id
        OG002
        lower Limit
        30.99
        upper Limit
        56.74
        value
        43.5
    title
    Week 28
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        26.00
        upper Limit
        52.43
        value
        38.6
      2. group Id
        OG001
        lower Limit
        29.23
        upper Limit
        56.79
        value
        42.6
      3. group Id
        OG002
        lower Limit
        28.05
        upper Limit
        53.55
        value
        40.3
    title
    Week 40
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        26.00
        upper Limit
        52.43
        value
        38.6
      2. group Id
        OG001
        lower Limit
        32.62
        upper Limit
        60.39
        value
        46.3
      3. group Id
        OG002
        lower Limit
        29.51
        upper Limit
        55.15
        value
        41.9
    title
    Week 52
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.56
        upper Limit
        54.18
        value
        40.4
      2. group Id
        OG001
        lower Limit
        24.29
        upper Limit
        51.26
        value
        37.0
      3. group Id
        OG002
        lower Limit
        29.51
        upper Limit
        55.15
        value
        41.9
    title
    Week 64
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.40
        upper Limit
        47.06
        value
        33.3
      2. group Id
        OG001
        lower Limit
        30.92
        upper Limit
        58.60
        value
        44.4
      3. group Id
        OG002
        lower Limit
        32.48
        upper Limit
        58.32
        value
        45.2
    title
    Week 76
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.56
        upper Limit
        54.18
        value
        40.4
      2. group Id
        OG001
        lower Limit
        29.23
        upper Limit
        56.79
        value
        42.6
      3. group Id
        OG002
        lower Limit
        32.48
        upper Limit
        58.32
        value
        45.2
    title
    Week 88
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.56
        upper Limit
        54.18
        value
        40.4
      2. group Id
        OG001
        lower Limit
        27.57
        upper Limit
        54.97
        value
        40.7
      3. group Id
        OG002
        lower Limit
        33.98
        upper Limit
        59.88
        value
        46.8
    title
    Week 100
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.45
        upper Limit
        50.66
        value
        36.8
      2. group Id
        OG001
        lower Limit
        30.92
        upper Limit
        58.60
        value
        44.4
      3. group Id
        OG002
        lower Limit
        28.05
        upper Limit
        53.55
        value
        40.3
    title
    Week 112
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.56
        upper Limit
        54.18
        value
        40.4
      2. group Id
        OG001
        lower Limit
        19.52
        upper Limit
        45.55
        value
        31.5
      3. group Id
        OG002
        lower Limit
        29.51
        upper Limit
        55.15
        value
        41.9
    title
    Week 124
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.45
        upper Limit
        50.66
        value
        36.8
      2. group Id
        OG001
        lower Limit
        22.68
        upper Limit
        49.38
        value
        35.2
      3. group Id
        OG002
        lower Limit
        30.99
        upper Limit
        56.74
        value
        43.5
    title
    Week 136
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.56
        upper Limit
        54.18
        value
        40.4
      2. group Id
        OG001
        lower Limit
        21.09
        upper Limit
        47.47
        value
        33.3
      3. group Id
        OG002
        lower Limit
        30.99
        upper Limit
        56.74
        value
        43.5
    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 \< 2.5 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
    Control Arm (Octreotide or Lanreotide) Extension
param Type
NUMBER
population Description
Full analysis set (FAS): comprised all patients who were randomized. Following the intent-to-treat principle, patients were analyzed according to the study drug they were assigned to at randomization and actual stratum.
reporting Status
POSTED
time Frame
Extension baseline up to approximately week 268
title
Percentage of Patients With Mean GH < 2.5 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

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

Preserved source evidence · Not medical advice