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NCT02632786 · OUTCOME

6MWT Distance

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
MEDIAN
Unit
meters
Interval / dispersion
Inter-Quartile Range
Time frame
Baseline to 12 months of treatment

What was measured

Change in 6 Minute Walk Test (6MWT) Distance (meters)

Analysis population: ITT 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/kg66
Placebo63

Reported measurements

Source class 1
Values in meters · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
NEOD001 24 mg/kg19.25Not reported-21.7559.37Not reported
Placebo8.00Not reported-24.9947.24Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -11.50
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    23.00
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8992
    param Type
    Mean Difference (Net)
    param Value
    5.00
    statistical Method
    ANCOVA
Complete source fields
analyses
  1. ci Lower Limit
    -11.50
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    23.00
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8992
    param Type
    Mean Difference (Net)
    param Value
    5.00
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -21.75
        upper Limit
        59.37
        value
        19.25
      2. group Id
        OG001
        lower Limit
        -24.99
        upper Limit
        47.24
        value
        8.00
denoms
  1. counts
    1. group Id
      OG000
      value
      66
    2. group Id
      OG001
      value
      63
    units
    Participants
description
Change in 6 Minute Walk Test (6MWT) Distance (meters)
dispersion Type
Inter-Quartile Range
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
MEDIAN
population Description
ITT Population
reporting Status
POSTED
time Frame
Baseline to 12 months of treatment
title
6MWT Distance
type
SECONDARY
unit Of Measure
meters

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

Preserved source evidence · Not medical advice