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NCT01283542 · OUTCOME

Tumor Volume Change From Baseline in Main Phase (FAS)

Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma. · Source last updated 2019-04-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
cm^3
Interval / dispersion
95% Confidence Interval
Time frame
baseline to week 4, 12, 24

What was measured

Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.

Analysis population: number of participants with evaluable data varied across visits

Groups in this outcome

Pasireotide LAR

All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks

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 LAR20

Reported measurements

Main Week 4

Analysis denominator · Participants

GroupSource count
Pasireotide LAR20
Values in cm^3 · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR1.25Not reported-1.704.20Not reported
Main Week 12

Analysis denominator · Participants

GroupSource count
Pasireotide LAR19
Values in cm^3 · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR0.66Not reported-0.451.76Not reported
Main Week 24

Analysis denominator · Participants

GroupSource count
Pasireotide LAR20
Values in cm^3 · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR0.23Not reported-1.241.71Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.70
        upper Limit
        4.20
        value
        1.25
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    Main Week 4
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.45
        upper Limit
        1.76
        value
        0.66
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      units
      Participants
    title
    Main Week 12
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.24
        upper Limit
        1.71
        value
        0.23
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    Main Week 24
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
dispersion Type
95% Confidence Interval
groups
  1. description
    All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks
    id
    OG000
    title
    Pasireotide LAR
param Type
MEAN
population Description
number of participants with evaluable data varied across visits
reporting Status
POSTED
time Frame
baseline to week 4, 12, 24
title
Tumor Volume Change From Baseline in Main Phase (FAS)
type
SECONDARY
unit Of Measure
cm^3

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

Preserved source evidence · Not medical advice