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NCT01283542 · OUTCOME

Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (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 participants
Interval / dispersion
95% Confidence Interval
Time frame
Baseline up to 24 weeks

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. A change ≥ 20% in the original volume of the tumor was considered to be clinically significant. Evaluable participants required tumor volume assessment at baseline and at week 24.

Analysis population: Evaluable participants required tumor volume assessment at baseline and at week 24

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 LAR12

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR16.7Not reported2.148.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.1
        upper Limit
        48.4
        value
        16.7
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    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. A change ≥ 20% in the original volume of the tumor was considered to be clinically significant. Evaluable participants required tumor volume assessment at baseline and at week 24.
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
NUMBER
population Description
Evaluable participants required tumor volume assessment at baseline and at week 24
reporting Status
POSTED
time Frame
Baseline up to 24 weeks
title
Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice