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NCT01673646 · OUTCOME

Change From Baseline in Prolactin

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
MEDIAN
Unit
pmol/L
Interval / dispersion
Full Range
Time frame
Baseline, Months 3, 6, 9, 12

What was measured

Change in prolactin levels from baseline

Analysis population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. Protocol allowed to change treatment dose (eg, 20mg -\> 40mg -\>20mg -\> 40mg -\>60mg) based on efficacy and safety after 3month treatment. So we combined Arms/groups.

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 pmol/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Pasireotide LAR - All Participants-43.00Not reported-609.001087.00Not reported
Month 6
Values in pmol/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Pasireotide LAR - All Participants0.00Not reported-435.00217.00Not reported
Month 9
Values in pmol/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Pasireotide LAR - All Participants0.00Not reported-479.00913.00Not reported
Month 12
Values in pmol/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Pasireotide LAR - All Participants0.00Not reported-653.00217.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -609.00
        upper Limit
        1087.00
        value
        -43.00
    title
    Month 3
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -435.00
        upper Limit
        217.00
        value
        0.00
    title
    Month 6
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -479.00
        upper Limit
        913.00
        value
        0.00
    title
    Month 9
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -653.00
        upper Limit
        217.00
        value
        0.00
    title
    Month 12
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Change in prolactin levels from baseline
dispersion Type
Full Range
groups
  1. description
    All patients randomized regardless of pasireotide LAR dose.
    id
    OG000
    title
    Pasireotide LAR - All Participants
param Type
MEDIAN
population Description
FAS: Comprises all patients to whom study treatment has been assigned by randomization. Protocol allowed to change treatment dose (eg, 20mg -\> 40mg -\>20mg -\> 40mg -\>60mg) based on efficacy and safety after 3month treatment. So we combined Arms/groups.
reporting Status
POSTED
time Frame
Baseline, Months 3, 6, 9, 12
title
Change From Baseline in Prolactin
type
SECONDARY
unit Of Measure
pmol/L

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

Preserved source evidence · Not medical advice