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NCT01283542 · OUTCOME

Mean ACTH and Estradiol 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
pg/mL
Interval / dispersion
Standard Deviation
Time frame
Baseline and at weeks 24, 48, 96

What was measured

Hormone levels, including those of growth hormone (GH),insulin-like growth factor 1 (IGF-1), follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free thyroxine (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

ACTH

Analysis denominator · Participants

GroupSource count
Baseline14
Week 2416
Week 489
Week 9610
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Baseline28.9137.07Not reportedNot reportedNot reported
Week 2423.1831.67Not reportedNot reportedNot reported
Week 4836.0633.09Not reportedNot reportedNot reported
Week 9629.9026.83Not reportedNot reportedNot reported
Estradiol

Analysis denominator · Participants

GroupSource count
Baseline11
Week 2410
Week 487
Week 967
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Baseline35.7221.03Not reportedNot reportedNot reported
Week 2432.1217.71Not reportedNot reportedNot reported
Week 4834.6914.74Not reportedNot reportedNot reported
Week 9619.9815.78Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        37.07
        value
        28.91
      2. group Id
        OG001
        spread
        31.67
        value
        23.18
      3. group Id
        OG002
        spread
        33.09
        value
        36.06
      4. group Id
        OG003
        spread
        26.83
        value
        29.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        16
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        10
      units
      Participants
    title
    ACTH
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.03
        value
        35.72
      2. group Id
        OG001
        spread
        17.71
        value
        32.12
      3. group Id
        OG002
        spread
        14.74
        value
        34.69
      4. group Id
        OG003
        spread
        15.78
        value
        19.98
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        7
      units
      Participants
    title
    Estradiol
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 growth hormone (GH),insulin-like growth factor 1 (IGF-1), follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free thyroxine (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 ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)
type
SECONDARY
unit Of Measure
pg/mL

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

Preserved source evidence · Not medical advice