Skip to content
← Full study record

NCT00958841 · OUTCOME

Percentage of Responders at Month 6 - Individual NETs

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
percentage of participants
Interval / dispersion
Not reported
Time frame
6 months

What was measured

Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.

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.

Groups in this outcome

Gastrinoma

One of the 10 types of PNETs analyzed

Prolactinoma

One of the 10 types of PNETs analyzed.

Nelson's Syndrome

based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.

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

Analysis denominator · Participants

GroupSource count
Gastrinoma13
Prolactinoma37
Nelson's Syndrome14

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gastrinoma46.2Not reportedNot reportedNot reportedNot reported
Prolactinoma21.6Not reportedNot reportedNot reportedNot reported
Nelson's Syndrome50.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        46.2
      2. group Id
        OG001
        value
        21.6
      3. group Id
        OG002
        value
        50.0
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      37
    3. group Id
      OG002
      value
      14
    units
    Participants
description
Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.
groups
  1. description
    One of the 10 types of PNETs analyzed
    id
    OG000
    title
    Gastrinoma
  2. description
    One of the 10 types of PNETs analyzed.
    id
    OG001
    title
    Prolactinoma
  3. description
    based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
    id
    OG002
    title
    Nelson's Syndrome
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.
reporting Status
POSTED
time Frame
6 months
title
Percentage of Responders at Month 6 - Individual NETs
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice