Skip to content
← Full study record

NCT01582061 · OUTCOME

Percent Change From Baseline in Insulin Growth Factor - 1 (IGF - 1) Values

An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease. · Source last updated 2018-06-19

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

Measure
MEAN
Unit
percent change of ng/ml
Interval / dispersion
Standard Deviation
Time frame
Baseline, week 12, 24 and 48

What was measured

Descriptive summary of the effect of pasireotide on IGF-1

Analysis population: Number of patients with available data differed at visits

Groups in this outcome

Pasireotide 600 μg

Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.

Pasireotide 900 μg

Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day

All Patients

Patients received pasireotide 600 μg or 900 μg BID

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 600 μg48
Pasireotide 900 μg53
All Patients101

Reported measurements

Week 12

Analysis denominator · Participants

GroupSource count
Pasireotide 600 μg34
Pasireotide 900 μg44
All Patients78
Values in percent change of ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide 600 μg-53.423.66Not reportedNot reportedNot reported
Pasireotide 900 μg-57.823.93Not reportedNot reportedNot reported
All Patients-55.923.76Not reportedNot reportedNot reported
Week 24

Analysis denominator · Participants

GroupSource count
Pasireotide 600 μg23
Pasireotide 900 μg29
All Patients52
Values in percent change of ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide 600 μg-49.226.56Not reportedNot reportedNot reported
Pasireotide 900 μg-56.226.55Not reportedNot reportedNot reported
All Patients-53.126.53Not reportedNot reportedNot reported
Week 48

Analysis denominator · Participants

GroupSource count
Pasireotide 600 μg16
Pasireotide 900 μg21
All Patients37
Values in percent change of ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide 600 μg-41.835.72Not reportedNot reportedNot reported
Pasireotide 900 μg-52.121.87Not reportedNot reportedNot reported
All Patients-47.628.71Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.66
        value
        -53.4
      2. group Id
        OG001
        spread
        23.93
        value
        -57.8
      3. group Id
        OG002
        spread
        23.76
        value
        -55.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        44
      3. group Id
        OG002
        value
        78
      units
      Participants
    title
    Week 12
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.56
        value
        -49.2
      2. group Id
        OG001
        spread
        26.55
        value
        -56.2
      3. group Id
        OG002
        spread
        26.53
        value
        -53.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        29
      3. group Id
        OG002
        value
        52
      units
      Participants
    title
    Week 24
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.72
        value
        -41.8
      2. group Id
        OG001
        spread
        21.87
        value
        -52.1
      3. group Id
        OG002
        spread
        28.71
        value
        -47.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        37
      units
      Participants
    title
    Week 48
denoms
  1. counts
    1. group Id
      OG000
      value
      48
    2. group Id
      OG001
      value
      53
    3. group Id
      OG002
      value
      101
    units
    Participants
description
Descriptive summary of the effect of pasireotide on IGF-1
dispersion Type
Standard Deviation
groups
  1. description
    Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined: 600 μg bid group includes all patients whose mean daily dose \< 1500 μg /day.
    id
    OG000
    title
    Pasireotide 600 μg
  2. description
    Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined : 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
    id
    OG001
    title
    Pasireotide 900 μg
  3. description
    Patients received pasireotide 600 μg or 900 μg BID
    id
    OG002
    title
    All Patients
param Type
MEAN
population Description
Number of patients with available data differed at visits
reporting Status
POSTED
time Frame
Baseline, week 12, 24 and 48
title
Percent Change From Baseline in Insulin Growth Factor - 1 (IGF - 1) Values
type
SECONDARY
unit Of Measure
percent change of ng/ml

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

Preserved source evidence · Not medical advice