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NCT01283542 · OUTCOME

Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS)

Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma. · Source last updated 2019-04-26

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Baseline and at weeks 24, 48, 96

What was measured

Hormone levels, including those of GH, IGF-1, and prolactin were evaluated by a central lab

Analysis population: number of participants with evaluable data varied across visits

Groups in this outcome

Baseline

Baseline of Main Phase

Week 24

Week 24 of Main Phase

Week 48

Week 48 of Extension Phase

Week 96

Week 96 of 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
Baseline20
Week 2420
Week 4813
Week 9611

Reported measurements

GH

Analysis denominator · Participants

GroupSource count
Baseline19
Week 2417
Week 4812
Week 969
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Baseline0.310.63Not reportedNot reportedNot reported
Week 241.114.10Not reportedNot reportedNot reported
Week 480.150.15Not reportedNot reportedNot reported
Week 960.120.07Not reportedNot reportedNot reported
IGF-1

Analysis denominator · Participants

GroupSource count
Baseline17
Week 2415
Week 4812
Week 969
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Baseline130.7344.4Not reportedNot reportedNot reported
Week 2472.5935.55Not reportedNot reportedNot reported
Week 4866.2331.46Not reportedNot reportedNot reported
Week 9670.8232.67Not reportedNot reportedNot reported
Prolactin

Analysis denominator · Participants

GroupSource count
Baseline20
Week 2416
Week 4812
Week 9610
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Baseline16.9012.91Not reportedNot reportedNot reported
Week 2413.8917.32Not reportedNot reportedNot reported
Week 489.036.27Not reportedNot reportedNot reported
Week 967.628.33Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.63
        value
        0.31
      2. group Id
        OG001
        spread
        4.10
        value
        1.11
      3. group Id
        OG002
        spread
        0.15
        value
        0.15
      4. group Id
        OG003
        spread
        0.07
        value
        0.12
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        9
      units
      Participants
    title
    GH
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        44.4
        value
        130.73
      2. group Id
        OG001
        spread
        35.55
        value
        72.59
      3. group Id
        OG002
        spread
        31.46
        value
        66.23
      4. group Id
        OG003
        spread
        32.67
        value
        70.82
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        15
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        9
      units
      Participants
    title
    IGF-1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.91
        value
        16.90
      2. group Id
        OG001
        spread
        17.32
        value
        13.89
      3. group Id
        OG002
        spread
        6.27
        value
        9.03
      4. group Id
        OG003
        spread
        8.33
        value
        7.62
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        16
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        10
      units
      Participants
    title
    Prolactin
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      20
    3. group Id
      OG002
      value
      13
    4. group Id
      OG003
      value
      11
    units
    Participants
description
Hormone levels, including those of GH, IGF-1, and prolactin were evaluated by a central lab
dispersion Type
Standard Deviation
groups
  1. description
    Baseline of Main Phase
    id
    OG000
    title
    Baseline
  2. description
    Week 24 of Main Phase
    id
    OG001
    title
    Week 24
  3. description
    Week 48 of Extension Phase
    id
    OG002
    title
    Week 48
  4. description
    Week 96 of Extension Phase
    id
    OG003
    title
    Week 96
param Type
MEAN
population Description
number of participants with evaluable data varied across visits
reporting Status
POSTED
time Frame
Baseline and at weeks 24, 48, 96
title
Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS)
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice