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NCT01283542 · OUTCOME

Mean Testosterone and Free T4 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/dL
Interval / dispersion
Standard Deviation
Time frame
Baseline and at weeks 24, 48, 96

What was measured

Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab

Analysis population: 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

Testosterone

Analysis denominator · Participants

GroupSource count
Baseline8
Week 245
Week 485
Week 967
Values in ng/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Baseline452.21214.52Not reportedNot reportedNot reported
Week 24372.72205.25Not reportedNot reportedNot reported
Week 48517.52200.64Not reportedNot reportedNot reported
Week 96382.10179.79Not reportedNot reportedNot reported
Free T4

Analysis denominator · Participants

GroupSource count
Baseline18
Week 2417
Week 4812
Week 9610
Values in ng/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Baseline1.070.12Not reportedNot reportedNot reported
Week 241.130.18Not reportedNot reportedNot reported
Week 481.170.17Not reportedNot reportedNot reported
Week 961.040.25Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        214.52
        value
        452.21
      2. group Id
        OG001
        spread
        205.25
        value
        372.72
      3. group Id
        OG002
        spread
        200.64
        value
        517.52
      4. group Id
        OG003
        spread
        179.79
        value
        382.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        7
      units
      Participants
    title
    Testosterone
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.12
        value
        1.07
      2. group Id
        OG001
        spread
        0.18
        value
        1.13
      3. group Id
        OG002
        spread
        0.17
        value
        1.17
      4. group Id
        OG003
        spread
        0.25
        value
        1.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        10
      units
      Participants
    title
    Free T4
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, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), 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
participants with evaluable data varied across visits
reporting Status
POSTED
time Frame
Baseline and at weeks 24, 48, 96
title
Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS)
type
SECONDARY
unit Of Measure
ng/dL

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

Preserved source evidence · Not medical advice