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NCT01794793 · OUTCOME

Percentage of Patients With Clinical Benefit as Assessed by the Investigator

Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies · Source last updated 2024-10-01

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline up to approximately 10 years

What was measured

Efficacy was assessed by the investigator at each scheduled visit using a binary (yes/no) response confirming the investigator's judgement of clinical benefit (via the question: "Does investigator confirm that the subject continues to have clinical benefit from the study treatment"). No other measures of efficacy were used in this study.

Analysis population: Number of patients judged by the investigator to be clinically benefitting from treatment.

Groups in this outcome

Pasireotide Subcutaneous

0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines. Cabergoline may be combined in this arm for Cushing's Disease and Acromegaly patients.

Pasireotide Long Acting Release (LAR)

10mg, 20mg, 40mg and 60mg. All doses to be taken q28days i.m. Strength is dependent on parent study guidelines

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 Subcutaneous38
Pasireotide Long Acting Release (LAR)299

Reported measurements

Month 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide Subcutaneous29Not reportedNot reportedNot reportedNot reported
Pasireotide Long Acting Release (LAR)256Not reportedNot reportedNot reportedNot reported
Month 6
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide Subcutaneous28Not reportedNot reportedNot reportedNot reported
Pasireotide Long Acting Release (LAR)250Not reportedNot reportedNot reportedNot reported
Month 12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide Subcutaneous21Not reportedNot reportedNot reportedNot reported
Pasireotide Long Acting Release (LAR)234Not reportedNot reportedNot reportedNot reported
Month 18
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide Subcutaneous19Not reportedNot reportedNot reportedNot reported
Pasireotide Long Acting Release (LAR)216Not reportedNot reportedNot reportedNot reported
Month 24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide Subcutaneous17Not reportedNot reportedNot reportedNot reported
Pasireotide Long Acting Release (LAR)198Not reportedNot reportedNot reportedNot reported
Month 36
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide Subcutaneous14Not reportedNot reportedNot reportedNot reported
Pasireotide Long Acting Release (LAR)177Not reportedNot reportedNot reportedNot reported
Month 48
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide Subcutaneous15Not reportedNot reportedNot reportedNot reported
Pasireotide Long Acting Release (LAR)162Not reportedNot reportedNot reportedNot reported
Month 60
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide Subcutaneous12Not reportedNot reportedNot reportedNot reported
Pasireotide Long Acting Release (LAR)140Not reportedNot reportedNot reportedNot reported
Month 72
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide Subcutaneous12Not reportedNot reportedNot reportedNot reported
Pasireotide Long Acting Release (LAR)98Not reportedNot reportedNot reportedNot reported
Month 84
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide Subcutaneous8Not reportedNot reportedNot reportedNot reported
Pasireotide Long Acting Release (LAR)21Not reportedNot reportedNot reportedNot reported
Month 96
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide Subcutaneous5Not reportedNot reportedNot reportedNot reported
Pasireotide Long Acting Release (LAR)1Not reportedNot reportedNot reportedNot reported
Month 108
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide Subcutaneous5Not reportedNot reportedNot reportedNot reported
Pasireotide Long Acting Release (LAR)1Not reportedNot reportedNot reportedNot reported
Month 120
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide Subcutaneous2Not reportedNot reportedNot reportedNot reported
Pasireotide Long Acting Release (LAR)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        256
    title
    Month 3
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        250
    title
    Month 6
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        234
    title
    Month 12
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        216
    title
    Month 18
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        198
    title
    Month 24
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        177
    title
    Month 36
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        162
    title
    Month 48
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        140
    title
    Month 60
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        98
    title
    Month 72
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        21
    title
    Month 84
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        1
    title
    Month 96
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        1
    title
    Month 108
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      299
    units
    Participants
description
Efficacy was assessed by the investigator at each scheduled visit using a binary (yes/no) response confirming the investigator's judgement of clinical benefit (via the question: "Does investigator confirm that the subject continues to have clinical benefit from the study treatment"). No other measures of efficacy were used in this study.
groups
  1. description
    0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines. Cabergoline may be combined in this arm for Cushing's Disease and Acromegaly patients.
    id
    OG000
    title
    Pasireotide Subcutaneous
  2. description
    10mg, 20mg, 40mg and 60mg. All doses to be taken q28days i.m. Strength is dependent on parent study guidelines
    id
    OG001
    title
    Pasireotide Long Acting Release (LAR)
param Type
COUNT_OF_PARTICIPANTS
population Description
Number of patients judged by the investigator to be clinically benefitting from treatment.
reporting Status
POSTED
time Frame
Baseline up to approximately 10 years
title
Percentage of Patients With Clinical Benefit as Assessed by the Investigator
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice