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NCT00958841 · OUTCOME

PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker

Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin · Source last updated 2016-07-26

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline, month 6

What was measured

Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6.

Analysis population: The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.

Groups in this outcome

All PiNETS (Prolactinoma)

One of the 10 types of PiNETs analyzed

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
All PiNETS (Prolactinoma)39

Reported measurements

Baseline
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All PiNETS (Prolactinoma)7Not reportedNot reportedNot reportedNot reported
Month 6
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All PiNETS (Prolactinoma)9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Month 6
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    units
    Participants
description
Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6.
groups
  1. description
    One of the 10 types of PiNETs analyzed
    id
    OG000
    title
    All PiNETS (Prolactinoma)
param Type
NUMBER
population Description
The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.
reporting Status
POSTED
time Frame
Baseline, month 6
title
PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice