NCT02312206 · OUTCOME

Time to Composite of All-cause Mortality or Cardiac Hospitalization

The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis · Source last updated 2023-11-14

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: Randomization until the date of death or cardiac hospitalization, up to 32 months

What was measured

Time to all-cause mortality death occurring after the first infusion of study drug or cardiac hospitalization as adjudicated by the CEC occurring at least 91 days after first infusion of study drug through last subject last visit, whichever came first

Analysis population: ITT Population

Groups in this outcome

NEOD001 (24 mg/kg) + Standard of Care

NEOD001, 24 mg/kg IV every 4 weeks on top of Standard of Care

Placebo + Standard of Care

Placebo 0.9% Saline IV every 4 weeks on top of Standard of Care

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

Analysis denominator · Participants

Group	Source count
NEOD001 (24 mg/kg) + Standard of Care	130
Placebo + Standard of Care	130

Reported measurements

Source class 1

Number of Subjects Who Died or Experienced Cardiac Hospitalization

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
NEOD001 (24 mg/kg) + Standard of Care	56	Not reported	Not reported	Not reported	Not reported
Placebo + Standard of Care	62	Not reported	Not reported	Not reported	Not reported

Number of Subjects Censored

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
NEOD001 (24 mg/kg) + Standard of Care	74	Not reported	Not reported	Not reported	Not reported
Placebo + Standard of Care	68	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
0.5735
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.1889
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.3028
param Type
Hazard Ratio (HR)
param Value
0.826
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.5735
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.1889
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.3028
param Type
Hazard Ratio (HR)
param Value
0.826
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
value
56
group Id
OG001
value
62
title
Number of Subjects Who Died or Experienced Cardiac Hospitalization
measurements
group Id
OG000
value
74
group Id
OG001
value
68
title
Number of Subjects Censored

denoms

counts
group Id
OG000
value
130
group Id
OG001
value
130
units
Participants

description

groups

description
NEOD001, 24 mg/kg IV every 4 weeks on top of Standard of Care
id
OG000
title
NEOD001 (24 mg/kg) + Standard of Care
description
Placebo 0.9% Saline IV every 4 weeks on top of Standard of Care
id
OG001
title
Placebo + Standard of Care

param Type

COUNT_OF_PARTICIPANTS

population Description

ITT Population

reporting Status

POSTED

time Frame

Randomization until the date of death or cardiac hospitalization, up to 32 months

title

Time to Composite of All-cause Mortality or Cardiac Hospitalization

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice