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NCT01673646 · OUTCOME

Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Extension Phase)

Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism · Source last updated 2019-09-16

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
Months 18, 24

What was measured

Percentage of participants with the normalization of IGF-1 to within normal limits (age and sex related) at 18 and 24 months of study. treatment

Analysis population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. The protocol allowed frequent dose changes even extension phase. In this case, separate data is not meaningful.

Groups in this outcome

Pasireotide LAR - All Participants

All patients randomized regardless of pasireotide LAR dose.

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 - All Participants33

Reported measurements

Month 18

Analysis denominator · Participants

GroupSource count
Pasireotide LAR - All Participants24
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR - All Participants16.7Not reported4.737.4Not reported
Month 24

Analysis denominator · Participants

GroupSource count
Pasireotide LAR - All Participants23
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR - All Participants30.4Not reported13.252.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.7
        upper Limit
        37.4
        value
        16.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    Month 18
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.2
        upper Limit
        52.9
        value
        30.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    Month 24
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Percentage of participants with the normalization of IGF-1 to within normal limits (age and sex related) at 18 and 24 months of study. treatment
dispersion Type
95% Confidence Interval
groups
  1. description
    All patients randomized regardless of pasireotide LAR dose.
    id
    OG000
    title
    Pasireotide LAR - All Participants
param Type
NUMBER
population Description
FAS: Comprises all patients to whom study treatment has been assigned by randomization. The protocol allowed frequent dose changes even extension phase. In this case, separate data is not meaningful.
reporting Status
POSTED
time Frame
Months 18, 24
title
Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Extension Phase)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice