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NCT01673646 · OUTCOME

Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by 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
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Ctrough: Day 28 after each injection 1-3, Cmax: 3 months after injections 1 and 3

What was measured

Ctrough: The trough level concentration on day 28, 3 months post 1st, 2nd and 3rd injections of Pasireotide LAR. Cmax: The maximum concentration 3 months post the 1st injection and 3rd injection of LAR.

Analysis population: The pharmacokinetic (PK) analysis set (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

Ctrough Day 28, 1st inj

Analysis denominator · Participants

GroupSource count
Pasireotide LAR 20mg11
Pasireotide LAR 40mg11
Pasireotide LAR 60mg11
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR 20mg5.363.35Not reportedNot reportedNot reported
Pasireotide LAR 40mg8.415.26Not reportedNot reportedNot reported
Pasireotide LAR 60mg10.85.12Not reportedNot reportedNot reported
Ctrough Day 28, 2nd inj

Analysis denominator · Participants

GroupSource count
Pasireotide LAR 20mg11
Pasireotide LAR 40mg10
Pasireotide LAR 60mg11
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR 20mg5.862.38Not reportedNot reportedNot reported
Pasireotide LAR 40mg10.74.14Not reportedNot reportedNot reported
Pasireotide LAR 60mg15.09.12Not reportedNot reportedNot reported
Ctrough Day 28, 3rd inj

Analysis denominator · Participants

GroupSource count
Pasireotide LAR 20mg9
Pasireotide LAR 40mg8
Pasireotide LAR 60mg8
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR 20mg5.852.28Not reportedNot reportedNot reported
Pasireotide LAR 40mg12.26.75Not reportedNot reportedNot reported
Pasireotide LAR 60mg11.14.99Not reportedNot reportedNot reported
Cmax, 1st inj

Analysis denominator · Participants

GroupSource count
Pasireotide LAR 20mg11
Pasireotide LAR 40mg11
Pasireotide LAR 60mg11
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR 20mg7.193.48Not reportedNot reportedNot reported
Pasireotide LAR 40mg10.37.25Not reportedNot reportedNot reported
Pasireotide LAR 60mg17.013.7Not reportedNot reportedNot reported
Cmax, 3rd inj

Analysis denominator · Participants

GroupSource count
Pasireotide LAR 20mg9
Pasireotide LAR 40mg8
Pasireotide LAR 60mg8
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pasireotide LAR 20mg8.232.35Not reportedNot reportedNot reported
Pasireotide LAR 40mg17.39.61Not reportedNot reportedNot reported
Pasireotide LAR 60mg16.27.12Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.35
        value
        5.36
      2. group Id
        OG001
        spread
        5.26
        value
        8.41
      3. group Id
        OG002
        spread
        5.12
        value
        10.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    Ctrough Day 28, 1st inj
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.38
        value
        5.86
      2. group Id
        OG001
        spread
        4.14
        value
        10.7
      3. group Id
        OG002
        spread
        9.12
        value
        15.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    Ctrough Day 28, 2nd inj
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.28
        value
        5.85
      2. group Id
        OG001
        spread
        6.75
        value
        12.2
      3. group Id
        OG002
        spread
        4.99
        value
        11.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        8
      units
      Participants
    title
    Ctrough Day 28, 3rd inj
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.48
        value
        7.19
      2. group Id
        OG001
        spread
        7.25
        value
        10.3
      3. group Id
        OG002
        spread
        13.7
        value
        17.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    Cmax, 1st inj
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.35
        value
        8.23
      2. group Id
        OG001
        spread
        9.61
        value
        17.3
      3. group Id
        OG002
        spread
        7.12
        value
        16.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        8
      units
      Participants
    title
    Cmax, 3rd inj
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      11
    units
    Participants
description
Ctrough: The trough level concentration on day 28, 3 months post 1st, 2nd and 3rd injections of Pasireotide LAR. Cmax: The maximum concentration 3 months post the 1st injection and 3rd injection of LAR.
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
The pharmacokinetic (PK) analysis set (PAS) consists of full analysis set (FAS) who have evaluable PK concentration data.
reporting Status
POSTED
time Frame
Ctrough: Day 28 after each injection 1-3, Cmax: 3 months after injections 1 and 3
title
Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice