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NCT01673646 · OUTCOME

Total-group Response Rate (GH & IGF-1) Over Time (Core Phase)

Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism · Source last updated 2019-09-16

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Months 3, 6, 9 & 12

What was measured

Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) at 3, 6, 9 and 12 months

Analysis population: FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.

Groups in this outcome

Pasireotide LAR - All Participants

All patients randomized regardless of pasireotide LAR dose.

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 LAR - All Participants33

Reported measurements

Month 3
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR - All Participants18.2Not reported7.035.5Not reported
Month 6
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR - All Participants21.2Not reported9.038.9Not reported
Month 9
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR - All Participants21.2Not reported9.038.9Not reported
Month 12
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR - All Participants15.2Not reported5.131.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.0
        upper Limit
        35.5
        value
        18.2
    title
    Month 3
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.0
        upper Limit
        38.9
        value
        21.2
    title
    Month 6
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.0
        upper Limit
        38.9
        value
        21.2
    title
    Month 9
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.1
        upper Limit
        31.9
        value
        15.2
    title
    Month 12
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) at 3, 6, 9 and 12 months
dispersion Type
95% Confidence Interval
groups
  1. description
    All patients randomized regardless of pasireotide LAR dose.
    id
    OG000
    title
    Pasireotide LAR - All Participants
param Type
NUMBER
population Description
FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.
reporting Status
POSTED
time Frame
Months 3, 6, 9 & 12
title
Total-group Response Rate (GH & IGF-1) Over Time (Core Phase)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice