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NCT01673646 · OUTCOME

Change of Tumor Volume From Baseline

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
mm^3
Interval / dispersion
Full Range
Time frame
Baseline, Months 6 , 12

What was measured

This shows the change in tumor volume from baseline to month 6 and from baseline to month 12 in patients treated with pasireotide LAR.

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

Change from baseline @ Month 6
Values in mm^3 · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Pasireotide LAR - All Participants-21.0Not reported-6532.01002.0Not reported
Change from baseline @ Month 12
Values in mm^3 · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Pasireotide LAR - All Participants-1.00Not reported-4084.01085.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -6532.0
        upper Limit
        1002.0
        value
        -21.0
    title
    Change from baseline @ Month 6
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -4084.0
        upper Limit
        1085.0
        value
        -1.00
    title
    Change from baseline @ Month 12
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
This shows the change in tumor volume from baseline to month 6 and from baseline to month 12 in patients treated with pasireotide LAR.
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 6 , 12
title
Change of Tumor Volume From Baseline
type
SECONDARY
unit Of Measure
mm^3

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

Preserved source evidence · Not medical advice