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NCT01283542 · OUTCOME

Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% 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
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
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 LAR10
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide LAR10.0Not reportedNot reportedNot reportedNot reported
Extension Week 72

Analysis denominator · Participants

GroupSource count
Pasireotide LAR8
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide LAR12.5Not reportedNot reportedNot reportedNot reported
Extension Week 96

Analysis denominator · Participants

GroupSource count
Pasireotide LAR2
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide LAR50.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Extension Week 48
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Extension Week 72
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        50.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      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.
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
NUMBER
population Description
number of participants with evaluable data varied across visits
reporting Status
POSTED
time Frame
baseline to week 48, 72, 96
title
Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS)
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice