NCT04172467 · OUTCOME

Guideline Adherence and Susceptibility to Infection

Quality Assurance of Secondary Immunodeficiencies (SID) in CLL/MM Patients · Source last updated 2022-01-10

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

Measure: NUMBER
Unit: Number of infectious events
Interval / dispersion: Not reported
Time frame: Median study observation period of 18.2 months

What was measured

For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model for recurrent events. For effect estimation, hazard ratios are reported with 95% confidence interval in each case. GLAD-Score 2 is Reference, a higher hazard ratio means a higher susceptibility to infection.

Groups in this outcome

GLAD-Score 2

2 points for full GLAD

GLAD-Score 1

1 point for deviations in dose or interval (+/- 10%) or a late start of IgRT (\>28 days after a severe infection (≥ grade 3)

GLAD-Score 0

0 points for IgRT without indication (overuse) or omitted IgRT despite recommendation (underuse). Likewise, 0 points were awarded if both the dose and the interval deviated from the GL recommendations (e.g. underdosed single dose) or if IgRT was not started until more than 3 months after hypogammaglobulinemia and at least one severe infection

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
GLAD-Score 2	889
GLAD-Score 1	75
GLAD-Score 0	122

Reported measurements

Source class 1

Values in Number of infectious events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
GLAD-Score 2	250	Not reported	Not reported	Not reported	Not reported
GLAD-Score 1	63	Not reported	Not reported	Not reported	Not reported
GLAD-Score 0	221	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
3.72
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.42
group Description
For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model. This model is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis. The null hypothesis is that the GLAD-Score has no effect on susceptibility to infection.
group Ids
OG000
OG002
non Inferiority Comment
To estimate the relevance of guideline adherent treatment (GLAD) for the susceptibility to infection, full GLAD is taken as reference category.
non Inferiority Type
OTHER
p Value
<0.001
p Value Comment
For effect estimation, hazard ratios are reported with 95% confidence interval. The significance level is set to two-sided ≤ 5% (p ≤ 0.05).
param Type
Hazard Ratio (HR)
param Value
4.49
statistical Comment
The Model developed by Anderson and Gill (1982) is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis.
statistical Method
Regression, Cox
ci Lower Limit
1.98
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.21
group Description
For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model. This model is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis. The null hypothesis is that the GLAD-Score has no effect on susceptibility to infection.
group Ids
OG000
OG001
non Inferiority Comment
To estimate the relevance of guideline adherent treatment (GLAD) for the susceptibility to infection, full GLAD is taken as reference category.
non Inferiority Type
OTHER
p Value
<0.001
p Value Comment
For effect estimation, hazard ratios are reported with 95% confidence interval. The significance level is set to two-sided ≤ 5% (p ≤ 0.05).
param Type
Hazard Ratio (HR)
param Value
2.52
statistical Comment
The Model developed by Anderson and Gill (1982) is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis.
statistical Method
Regression, Cox

Complete source fields

analyses

ci Lower Limit
3.72
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.42
group Description
For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model. This model is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis. The null hypothesis is that the GLAD-Score has no effect on susceptibility to infection.
group Ids
OG000
OG002
non Inferiority Comment
To estimate the relevance of guideline adherent treatment (GLAD) for the susceptibility to infection, full GLAD is taken as reference category.
non Inferiority Type
OTHER
p Value
<0.001
p Value Comment
For effect estimation, hazard ratios are reported with 95% confidence interval. The significance level is set to two-sided ≤ 5% (p ≤ 0.05).
param Type
Hazard Ratio (HR)
param Value
4.49
statistical Comment
The Model developed by Anderson and Gill (1982) is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis.
statistical Method
Regression, Cox
ci Lower Limit
1.98
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.21
group Description
For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model. This model is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis. The null hypothesis is that the GLAD-Score has no effect on susceptibility to infection.
group Ids
OG000
OG001
non Inferiority Comment
To estimate the relevance of guideline adherent treatment (GLAD) for the susceptibility to infection, full GLAD is taken as reference category.
non Inferiority Type
OTHER
p Value
<0.001
p Value Comment
For effect estimation, hazard ratios are reported with 95% confidence interval. The significance level is set to two-sided ≤ 5% (p ≤ 0.05).
param Type
Hazard Ratio (HR)
param Value
2.52
statistical Comment
The Model developed by Anderson and Gill (1982) is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis.
statistical Method
Regression, Cox

classes

categories
measurements
group Id
OG000
value
250
group Id
OG001
value
63
group Id
OG002
value
221

denoms

counts
group Id
OG000
value
889
group Id
OG001
value
75
group Id
OG002
value
122
units
Participants

description

groups

description
2 points for full GLAD
id
OG000
title
GLAD-Score 2
description
1 point for deviations in dose or interval (+/- 10%) or a late start of IgRT (\>28 days after a severe infection (≥ grade 3)
id
OG001
title
GLAD-Score 1
description
0 points for IgRT without indication (overuse) or omitted IgRT despite recommendation (underuse). Likewise, 0 points were awarded if both the dose and the interval deviated from the GL recommendations (e.g. underdosed single dose) or if IgRT was not started until more than 3 months after hypogammaglobulinemia and at least one severe infection
id
OG002
title
GLAD-Score 0

param Type

NUMBER

reporting Status

POSTED

time Frame

Median study observation period of 18.2 months

title

Guideline Adherence and Susceptibility to Infection

type

SECONDARY

unit Of Measure

Number of infectious events

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Preserved source evidence · Not medical advice