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NCT02354508 · OUTCOME

Extension Phase: Percentage of Participants With Mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 and 72 (Overall by Baseline Diabetic Status)

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 participants achieving IGF-1 \<ULN at week 46, 60 and 72 overall by baseline diabetic status

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 Overall

These are the participants in the extension phase who received Pasireotide LAR

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 Overall88

Reported measurements

Week 48: Diabetic

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall43
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall11.6Not reported3.8925.08Not reported
Week 60: Diabetic

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall43
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall11.6Not reported3.8925.08Not reported
Week 72: Diabetic

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall43
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall11.6Not reported3.8925.08Not reported
Week 48: Pre-diabetic

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall36
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall11.1Not reported3.1126.06Not reported
Week 60: Pre-diabetic

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall36
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall16.7Not reported6.3732.81Not reported
Week 72: Pre-diabetic

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall36
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall8.3Not reported1.7522.47Not reported
Week 48: Non-diabetic

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall9
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall22.2Not reported2.8160.01Not reported
Week 60: Non-diabetic

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall9
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall22.2Not reported2.8160.01Not reported
Week 72: Non-diabetic

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall9
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall22.2Not reported2.8160.01Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.89
        upper Limit
        25.08
        value
        11.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      units
      Participants
    title
    Week 48: Diabetic
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.89
        upper Limit
        25.08
        value
        11.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      units
      Participants
    title
    Week 60: Diabetic
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.89
        upper Limit
        25.08
        value
        11.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      units
      Participants
    title
    Week 72: Diabetic
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.11
        upper Limit
        26.06
        value
        11.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Week 48: Pre-diabetic
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.37
        upper Limit
        32.81
        value
        16.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Week 60: Pre-diabetic
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.75
        upper Limit
        22.47
        value
        8.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Week 72: Pre-diabetic
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.81
        upper Limit
        60.01
        value
        22.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Week 48: Non-diabetic
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.81
        upper Limit
        60.01
        value
        22.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Week 60: Non-diabetic
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.81
        upper Limit
        60.01
        value
        22.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Week 72: Non-diabetic
denoms
  1. counts
    1. group Id
      OG000
      value
      88
    units
    Participants
description
Percentage of participants achieving IGF-1 \<ULN at week 46, 60 and 72 overall by baseline diabetic status
dispersion Type
95% Confidence Interval
groups
  1. description
    These are the participants in the extension phase who received Pasireotide LAR
    id
    OG000
    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 and IGF-1 < ULN at Weeks 48, 60 and 72 (Overall by Baseline Diabetic Status)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice