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NCT02632786 · OUTCOME

Hepatic Best Response

The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis · Source last updated 2019-04-05

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 through 12 months of treatment

What was measured

Alkaline Phosphatase response (Response or Non-Response \[Stable, Progression\]) from baseline through 12 months of treatment in subjects with hepatic involvement

Analysis population: Hepatic Evaluable Population

Groups in this outcome

NEOD001 24 mg/kg

NEOD001, 24 mg/kg IV every 4 weeks for 12 months

Placebo

Placebo, 0.9% Saline IV every 4 weeks for 12 months

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
NEOD001 24 mg/kg5
Placebo4

Reported measurements

Source class 1

Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NEOD001 24 mg/kg1Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported

Non-response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NEOD001 24 mg/kg4Not reportedNot reportedNot reportedNot reported
Placebo4Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4142
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4142
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      title
      Response
    2. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      title
      Non-response
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      4
    units
    Participants
description
Alkaline Phosphatase response (Response or Non-Response \[Stable, Progression\]) from baseline through 12 months of treatment in subjects with hepatic involvement
groups
  1. description
    NEOD001, 24 mg/kg IV every 4 weeks for 12 months
    id
    OG000
    title
    NEOD001 24 mg/kg
  2. description
    Placebo, 0.9% Saline IV every 4 weeks for 12 months
    id
    OG001
    title
    Placebo
param Type
COUNT_OF_PARTICIPANTS
population Description
Hepatic Evaluable Population
reporting Status
POSTED
time Frame
Baseline through 12 months of treatment
title
Hepatic Best Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice