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NCT02354508 · OUTCOME

Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36

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 36

What was measured

Percentage of patients who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, by previous treatment, type of therapy and overall.

Analysis population: Full Analysis Set (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

Lanreotide 120 mg

Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).

Octreotide 30 mg

Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .

Octreotide 40 mg

Participants were treated with octreotide 40 mg and assigned to either Group 1 (if 40mg octreotide was approved in the country) or Group 2 if 40mg octreotide was not approved in the country (before starting on Pasireotide in the Core phase).

Pasireotide LAR Monotherapy

Participants received pasireotide LAR only

Pasireotide With Concomitant Medication

Participants received pasireotide along with other concomitant medications.or octreotide 40 mg.

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
Lanreotide 120 mg26
Octreotide 30 mg23
Octreotide 40 mg39
Pasireotide LAR Monotherapy76
Pasireotide With Concomitant Medication12
Pasireotide LAR Overall88

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lanreotide 120 mg7.7Not reported0.9525.13Not reported
Octreotide 30 mg13.0Not reported2.7833.59Not reported
Octreotide 40 mg20.5Not reported9.3036.46Not reported
Pasireotide LAR Monotherapy17.1Not reported9.4327.47Not reported
Pasireotide With Concomitant Medication0.0Not reported0.0026.46Not reported
Pasireotide LAR Overall14.8Not reported8.1123.94Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.95
        upper Limit
        25.13
        value
        7.7
      2. group Id
        OG001
        lower Limit
        2.78
        upper Limit
        33.59
        value
        13.0
      3. group Id
        OG002
        lower Limit
        9.30
        upper Limit
        36.46
        value
        20.5
      4. group Id
        OG003
        lower Limit
        9.43
        upper Limit
        27.47
        value
        17.1
      5. group Id
        OG004
        lower Limit
        0.00
        upper Limit
        26.46
        value
        0.0
      6. group Id
        OG005
        lower Limit
        8.11
        upper Limit
        23.94
        value
        14.8
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    2. group Id
      OG001
      value
      23
    3. group Id
      OG002
      value
      39
    4. group Id
      OG003
      value
      76
    5. group Id
      OG004
      value
      12
    6. group Id
      OG005
      value
      88
    units
    Participants
description
Percentage of patients who achieved biochemical control defined as GH \<1μg/L and IGF-1 \<ULN at week 36, by previous treatment, type of therapy and overall.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were treated with lanreotide 120mg and assigned to Group 2 (before starting on Pasireotide in the Core phase).
    id
    OG000
    title
    Lanreotide 120 mg
  2. description
    Participants were treated with octreotide 30 mg and assigned to Group 2 (before starting on Pasireotide in the Core phase). .
    id
    OG001
    title
    Octreotide 30 mg
  3. description
    Participants were treated with octreotide 40 mg and assigned to either Group 1 (if 40mg octreotide was approved in the country) or Group 2 if 40mg octreotide was not approved in the country (before starting on Pasireotide in the Core phase).
    id
    OG002
    title
    Octreotide 40 mg
  4. description
    Participants received pasireotide LAR only
    id
    OG003
    title
    Pasireotide LAR Monotherapy
  5. description
    Participants received pasireotide along with other concomitant medications.or octreotide 40 mg.
    id
    OG004
    title
    Pasireotide With Concomitant Medication
  6. description
    This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
    id
    OG005
    title
    Pasireotide LAR Overall
param Type
NUMBER
population Description
Full Analysis Set (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 36
title
Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice