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NCT01794793 · OUTCOME

Incidence of Adverse Events to Evaluate Long Term Safety Data

Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies · Source last updated 2024-10-01

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 up to approximately 10 years

What was measured

Collect long term safety data, i.e. SAEs and AEs. SAES will be reviewed and reported as part of the regular pharmacovigilance activities.

Analysis population: The Safety Set included all patients who received at least one dose of study medication (pasireotide) after enrolling into the roll-over protocol

Groups in this outcome

All Subjects

Patients who were treated with and had benefitted from pasireotide in the parent studies remained enrolled in this study and were elegible for the analysis

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 Subjects337

Reported measurements

AEs : All grades
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects265Not reportedNot reportedNot reportedNot reported
AEs : Grades ≥3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects102Not reportedNot reportedNot reportedNot reported
Treatment-related AEs : All grades
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects127Not reportedNot reportedNot reportedNot reported
Treatment-related AEs : Grades ≥3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects39Not reportedNot reportedNot reportedNot reported
SAEs : All grades
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects91Not reportedNot reportedNot reportedNot reported
SAEs : Grades ≥3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects72Not reportedNot reportedNot reportedNot reported
Fatal SAEs : All grades
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects8Not reportedNot reportedNot reportedNot reported
Fatal SAEs : Grades ≥3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects8Not reportedNot reportedNot reportedNot reported
Treatment-related fatal SAEs : All grades
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects0Not reportedNot reportedNot reportedNot reported
Treatment-related fatal SAEs : Grades ≥3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects0Not reportedNot reportedNot reportedNot reported
AEs leading to discontinuation : All grades
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects20Not reportedNot reportedNot reportedNot reported
AEs leading to discontinuation : Grades ≥3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects11Not reportedNot reportedNot reportedNot reported
Treatment-related AEs leading to discontinuation : All grades
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects16Not reportedNot reportedNot reportedNot reported
Treatment-related AEs leading to discontinuation : Grades ≥3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects7Not reportedNot reportedNot reportedNot reported
AEs leading to dose adjustment/interruption : All grades
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects39Not reportedNot reportedNot reportedNot reported
AEs leading to dose adjustment/interruption : Grades ≥3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects13Not reportedNot reportedNot reportedNot reported
AEs requiring additional therapy : All grades
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects220Not reportedNot reportedNot reportedNot reported
AEs requiring additional therapy : Grades ≥3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Subjects62Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        265
    title
    AEs : All grades
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        102
    title
    AEs : Grades ≥3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        127
    title
    Treatment-related AEs : All grades
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        39
    title
    Treatment-related AEs : Grades ≥3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        91
    title
    SAEs : All grades
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        72
    title
    SAEs : Grades ≥3
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Fatal SAEs : All grades
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Fatal SAEs : Grades ≥3
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Treatment-related fatal SAEs : All grades
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Treatment-related fatal SAEs : Grades ≥3
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    AEs leading to discontinuation : All grades
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    AEs leading to discontinuation : Grades ≥3
denoms
  1. counts
    1. group Id
      OG000
      value
      337
    units
    Participants
description
Collect long term safety data, i.e. SAEs and AEs. SAES will be reviewed and reported as part of the regular pharmacovigilance activities.
groups
  1. description
    Patients who were treated with and had benefitted from pasireotide in the parent studies remained enrolled in this study and were elegible for the analysis
    id
    OG000
    title
    All Subjects
param Type
NUMBER
population Description
The Safety Set included all patients who received at least one dose of study medication (pasireotide) after enrolling into the roll-over protocol
reporting Status
POSTED
time Frame
Baseline up to approximately 10 years
title
Incidence of Adverse Events to Evaluate Long Term Safety Data
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice