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NCT01673646 · OUTCOME

Summary of Pasireotide LAR PK Parameter of Accumulation Ratio Randomized Dose Level

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
MEAN
Unit
ratio
Interval / dispersion
Standard Deviation
Time frame
Day 28 after injections 1 and 3

What was measured

The accumulation ratio was calculated as a ratio of (Ctrough day28, 3rd injection/Ctrough day28, 1st injection).

Analysis population: PAS: Consists of full analysis set (FAS) who have evaluable PK concentration data

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 ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR 20mg1.330.530Not reportedNot reportedNot reported
Pasireotide LAR 40mg1.851.17Not reportedNot reportedNot reported
Pasireotide LAR 60mg1.641.41Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.530
        value
        1.33
      2. group Id
        OG001
        spread
        1.17
        value
        1.85
      3. group Id
        OG002
        spread
        1.41
        value
        1.64
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      11
    units
    Participants
description
The accumulation ratio was calculated as a ratio of (Ctrough day28, 3rd injection/Ctrough day28, 1st injection).
dispersion Type
Standard Deviation
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
MEAN
population Description
PAS: Consists of full analysis set (FAS) who have evaluable PK concentration data
reporting Status
POSTED
time Frame
Day 28 after injections 1 and 3
title
Summary of Pasireotide LAR PK Parameter of Accumulation Ratio Randomized Dose Level
type
SECONDARY
unit Of Measure
ratio

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

Preserved source evidence · Not medical advice