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NCT02632786 · OUTCOME

SF-36v2 PCS Score

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
LEAST_SQUARES_MEAN
Unit
score on a scale
Interval / dispersion
95% Confidence Interval
Time frame
Baseline to 12 months of treatment

What was measured

Change in Short Form-36 (SF-36 version 2) questionnaire Physical Component Summary \[PCS\] Score. PCS scores are calculated based on responses to specific Short Form-36 (version 2) questions using a weight scoring method. The lower the PCS score the more disability, the higher the score the less disability. A score of 50 is the mean in the US General Population and the standard deviation is 10. Minimum is 0 and maximum value is 100.

Analysis population: ITT population

Groups in this outcome

NEOD001 24mg/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 24mg/kg66
Placebo63

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NEOD001 24mg/kg0.19Not reported-1.832.22Not reported
Placebo0.97Not reported-0.992.93Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -3.37
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.81
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5563
    param Type
    Mean Difference (Net)
    param Value
    -0.78
    statistical Method
    Mixed Models Analysis
Complete source fields
analyses
  1. ci Lower Limit
    -3.37
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.81
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5563
    param Type
    Mean Difference (Net)
    param Value
    -0.78
    statistical Method
    Mixed Models Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.83
        upper Limit
        2.22
        value
        0.19
      2. group Id
        OG001
        lower Limit
        -0.99
        upper Limit
        2.93
        value
        0.97
denoms
  1. counts
    1. group Id
      OG000
      value
      66
    2. group Id
      OG001
      value
      63
    units
    Participants
description
Change in Short Form-36 (SF-36 version 2) questionnaire Physical Component Summary \[PCS\] Score. PCS scores are calculated based on responses to specific Short Form-36 (version 2) questions using a weight scoring method. The lower the PCS score the more disability, the higher the score the less disability. A score of 50 is the mean in the US General Population and the standard deviation is 10. Minimum is 0 and maximum value is 100.
dispersion Type
95% Confidence Interval
groups
  1. description
    NEOD001, 24 mg/kg IV every 4 weeks for 12 months
    id
    OG000
    title
    NEOD001 24mg/kg
  2. description
    Placebo, 0.9% Saline IV every 4 weeks for 12 months
    id
    OG001
    title
    Placebo
param Type
LEAST_SQUARES_MEAN
population Description
ITT population
reporting Status
POSTED
time Frame
Baseline to 12 months of treatment
title
SF-36v2 PCS Score
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice