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NCT01673646 · OUTCOME

GH Response at Month 3 by Randomized Dose

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
Month 3

What was measured

Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L at 3 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 20mg

Enrolled patients were randomized to 20mg pasireotide LAR.

Pasireotide LAR 40mg

Enrolled patients were randomized to 40mg pasireotide LAR.

Pasireotide LAR 60mg

Enrolled patients were randomized to 60mg pasireotide LAR.

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 20mg11
Pasireotide LAR 40mg11
Pasireotide LAR 60mg11

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pasireotide LAR 20mg27.3Not reported6.061.0Not reported
Pasireotide LAR 40mg45.5Not reported16.776.6Not reported
Pasireotide LAR 60mg18.2Not reported2.351.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.0
        upper Limit
        61.0
        value
        27.3
      2. group Id
        OG001
        lower Limit
        16.7
        upper Limit
        76.6
        value
        45.5
      3. group Id
        OG002
        lower Limit
        2.3
        upper Limit
        51.8
        value
        18.2
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      11
    units
    Participants
description
Percentage of participants with a reduction of mean GH levels to \< 2.5 µg/L at 3 months.
dispersion Type
95% Confidence Interval
groups
  1. description
    Enrolled patients were randomized to 20mg pasireotide LAR.
    id
    OG000
    title
    Pasireotide LAR 20mg
  2. description
    Enrolled patients were randomized to 40mg pasireotide LAR.
    id
    OG001
    title
    Pasireotide LAR 40mg
  3. description
    Enrolled patients were randomized to 60mg pasireotide LAR.
    id
    OG002
    title
    Pasireotide LAR 60mg
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
Month 3
title
GH Response at Month 3 by Randomized Dose
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice