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NCT02299089 · OUTCOME

To Assess the Symptoms of Carcinoid Syndrome (Number of Bowel Movements and Flushing) and the Use of Rescue Medication Versus Baseline (by Using Patient Diaries) (NET)

Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs) · Source last updated 2017-12-15

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 (Day 0), Day 84

What was measured

Number of bowel movements and flushing during period 0 and 1, data is presented as patients experience symptoms Bowel movement without flushing Bowel movement and flushing No Bowel movement or Flushing

Analysis population: Pharmacokinetic population

Groups in this outcome

CAM2029 10 mg q2w (NET)

CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot

CAM2029 20 mg q4w (NET)

CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot

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

Analysis denominator · Participants

GroupSource count
CAM2029 10 mg q2w (NET)1
CAM2029 20 mg q4w (NET)4

Reported measurements

Bowel movements without flushing
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CAM2029 10 mg q2w (NET)1Not reportedNot reportedNot reportedNot reported
CAM2029 20 mg q4w (NET)0Not reportedNot reportedNot reportedNot reported
Bowel movements with flushing
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CAM2029 10 mg q2w (NET)0Not reportedNot reportedNot reportedNot reported
CAM2029 20 mg q4w (NET)2Not reportedNot reportedNot reportedNot reported
No Bowel movement or Flushing
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CAM2029 10 mg q2w (NET)0Not reportedNot reportedNot reportedNot reported
CAM2029 20 mg q4w (NET)2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Bowel movements without flushing
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Bowel movements with flushing
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    No Bowel movement or Flushing
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      4
    units
    Participants
description
Number of bowel movements and flushing during period 0 and 1, data is presented as patients experience symptoms Bowel movement without flushing Bowel movement and flushing No Bowel movement or Flushing
groups
  1. description
    CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot
    id
    OG000
    title
    CAM2029 10 mg q2w (NET)
  2. description
    CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot
    id
    OG001
    title
    CAM2029 20 mg q4w (NET)
param Type
NUMBER
population Description
Pharmacokinetic population
reporting Status
POSTED
time Frame
Baseline (Day 0), Day 84
title
To Assess the Symptoms of Carcinoid Syndrome (Number of Bowel Movements and Flushing) and the Use of Rescue Medication Versus Baseline (by Using Patient Diaries) (NET)
type
OTHER_PRE_SPECIFIED
unit Of Measure
participants

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

Preserved source evidence · Not medical advice