NCT02728804 · OUTCOME

Association of Income and Cumulative Incidence Rate of Major Financial Hardship

S1417CD Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer · Source last updated 2023-01-26

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

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: Up to 12 months

What was measured

The cumulative incidence estimates of participants experiencing MFH within income groups. This estimate is calculated over a 12 month period; due to participant drop out throughout this period, the calculated cumulative incidence for the participants analyzed at the 12 month mark does not equate to a whole number. This is used to assess whether major financial hardship at one year differs by household income (\<$50,000 vs. \>=$50,000 and \<$100,000 vs. \>=$100,000). Household income is taken at baseline.

Analysis population: 294 total participants were analyzed which had baseline household income information available and either completed the 12-month evaluation or met the primary endpoint. The number of participants in the \<$50,000 arm and \>=$50,000 arm equal the total (294) participants analyzed. Similarly, the number of participants in the \<$100,000 arm and \>=$100,000 arm equal the total (294) participants analyzed.

Groups in this outcome

<$50,000

This group is comprised of eligible and evaluable participants whose yearly income is less than $50,000.

>=$50,000

This group is comprised of eligible and evaluable participants whose yearly income is at least $50,000.

<$100,000

This group is comprised of eligible and evaluable participants whose yearly income is less than $100,000.

>=$100,000

This group is comprised of eligible and evaluable participants whose yearly income is at least $100,000.

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
<$50,000	168
>=$50,000	126
<$100,000	239
>=$100,000	55

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
<$50,000	72.7	Not reported	65.6	78.6	Not reported
>=$50,000	69.1	Not reported	59.3	77.1	Not reported
<$100,000	72.9	Not reported	67.0	77.9	Not reported
>=$100,000	64.9	Not reported	45.6	78.8	Not reported

Source statistical analyses

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

ci Lower Limit
0.95
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.87
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.10
param Type
Hazard Ratio (HR)
param Value
1.33
statistical Comment
Covariate adjustment for insurance status, education, and sex.
statistical Method
Regression, Cox
ci Lower Limit
1.28
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.89
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY
p Value
0.002
param Type
Hazard Ratio (HR)
param Value
1.92
statistical Comment
Covariate adjustment for insurance status, education, and sex.
statistical Method
Regression, Cox

Complete source fields

analyses

ci Lower Limit
0.95
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.87
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.10
param Type
Hazard Ratio (HR)
param Value
1.33
statistical Comment
Covariate adjustment for insurance status, education, and sex.
statistical Method
Regression, Cox
ci Lower Limit
1.28
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.89
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY
p Value
0.002
param Type
Hazard Ratio (HR)
param Value
1.92
statistical Comment
Covariate adjustment for insurance status, education, and sex.
statistical Method
Regression, Cox

classes

categories
measurements
group Id
OG000
lower Limit
65.6
upper Limit
78.6
value
72.7
group Id
OG001
lower Limit
59.3
upper Limit
77.1
value
69.1
group Id
OG002
lower Limit
67.0
upper Limit
77.9
value
72.9
group Id
OG003
lower Limit
45.6
upper Limit
78.8
value
64.9

denoms

counts
group Id
OG000
value
168
group Id
OG001
value
126
group Id
OG002
value
239
group Id
OG003
value
55
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
This group is comprised of eligible and evaluable participants whose yearly income is less than $50,000.
id
OG000
title
<$50,000
description
This group is comprised of eligible and evaluable participants whose yearly income is at least $50,000.
id
OG001
title
>=$50,000
description
This group is comprised of eligible and evaluable participants whose yearly income is less than $100,000.
id
OG002
title
<$100,000
description
This group is comprised of eligible and evaluable participants whose yearly income is at least $100,000.
id
OG003
title
>=$100,000

param Type

NUMBER

population Description

294 total participants were analyzed which had baseline household income information available and either completed the 12-month evaluation or met the primary endpoint. The number of participants in the \<$50,000 arm and \>=$50,000 arm equal the total (294) participants analyzed. Similarly, the number of participants in the \<$100,000 arm and \>=$100,000 arm equal the total (294) participants analyzed.

reporting Status

POSTED

time Frame

Up to 12 months

title

Association of Income and Cumulative Incidence Rate of Major Financial Hardship

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice