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NCT01283542 · OUTCOME

Tumor Volume Change From Baseline in Extension 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
Standard Deviation
Time frame
baseline to week 48, 72, 96

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 LAR13

Reported measurements

Extension Week 48

Analysis denominator · Participants

GroupSource count
Pasireotide LAR13
Values in cm^3 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR0.532.19Not reportedNot reportedNot reported
Extension Week 72

Analysis denominator · Participants

GroupSource count
Pasireotide LAR12
Values in cm^3 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR-0.140.63Not reportedNot reportedNot reported
Extension Week 96

Analysis denominator · Participants

GroupSource count
Pasireotide LAR11
Values in cm^3 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR0.00.90Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.19
        value
        0.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Extension Week 48
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.63
        value
        -0.14
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Extension Week 72
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.90
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    Extension Week 96
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    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
Standard Deviation
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 48, 72, 96
title
Tumor Volume Change From Baseline in Extension Phase (FAS)
type
SECONDARY
unit Of Measure
cm^3

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

Preserved source evidence · Not medical advice