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NCT01673646 · OUTCOME

Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core 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 3, 6, 9, 12

What was measured

This refers to the percentage of participants with the normalization of insulin-like growth factor-1 (IGF-1) to within normal limits by visit.

Analysis population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.

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 3
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR - All Participants24.2Not reported11.142.3Not reported
Month 6
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR - All Participants33.3Not reported18.051.8Not reported
Month 9
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR - All Participants39.4Not reported22.957.9Not reported
Month 12
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR - All Participants27.3Not reported13.345.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.1
        upper Limit
        42.3
        value
        24.2
    title
    Month 3
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.0
        upper Limit
        51.8
        value
        33.3
    title
    Month 6
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.9
        upper Limit
        57.9
        value
        39.4
    title
    Month 9
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.3
        upper Limit
        45.5
        value
        27.3
    title
    Month 12
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
This refers to the percentage of participants with the normalization of insulin-like growth factor-1 (IGF-1) to within normal limits by visit.
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. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.
reporting Status
POSTED
time Frame
Months 3, 6, 9, 12
title
Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice