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NCT01253161 · OUTCOME

Adverse Events Possibly Related to Study Treatment

Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs) · Source last updated 2023-03-06

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

Measure
NUMBER
Unit
events
Interval / dispersion
Not reported
Time frame
Up to 48 months

What was measured

Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the NIH/NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).

Analysis population: All participants who received at least one dose of study drug

Groups in this outcome

Pasireotide LAR Treatment

The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg. Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.

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 LAR Treatment29

Reported measurements

Source class 1
Values in events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide LAR Treatment42Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        42
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    units
    Participants
description
Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the NIH/NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
groups
  1. description
    The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg. Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
    id
    OG000
    title
    Pasireotide LAR Treatment
param Type
NUMBER
population Description
All participants who received at least one dose of study drug
reporting Status
POSTED
time Frame
Up to 48 months
title
Adverse Events Possibly Related to Study Treatment
type
SECONDARY
unit Of Measure
events

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

Preserved source evidence · Not medical advice