NCT01459653 · OUTCOME

Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Cycle Level

Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor · Source last updated 2016-01-11

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

Measure: NUMBER
Unit: cycles
Interval / dispersion: Not reported
Time frame: All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

What was measured

Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of \<0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; ECOG: Eastern Cooperative Oncology Group; FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score.

Analysis population: Cycles of patients from evaluable sample with composite outcome data

Groups in this outcome

EP2006

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.

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
EP2006	1529

Analysis denominator · cycles

Group	Source count
EP2006	5193

Reported measurements

Source class 1

Values in cycles · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
EP2006	507	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
0.424
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.821
group Description
GIS (1 vs. 0) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.002
param Type
Odds Ratio (OR)
param Value
0.590
statistical Method
Regression, Logistic
tested Non Inferiority
false
ci Lower Limit
0.489
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.859
group Description
Zarzio duration: 4-5 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.003
param Type
Odds Ratio (OR)
param Value
0.644
statistical Method
Regression, Logistic
tested Non Inferiority
false
ci Lower Limit
0.398
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.842
group Description
Zarzio duration: 1-3 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.004
param Type
Odds Ratio (OR)
param Value
0.579
statistical Method
Regression, Logistic
tested Non Inferiority
false
ci Lower Limit
1.140
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.643
group Description
ECOG score (per 1 point) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.001
param Type
Odds Ratio (OR)
param Value
1.369
statistical Method
Regression, Logistic
tested Non Inferiority
false
ci Lower Limit
2.456
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
4.985
group Description
Concomitant antibiotic prophylaxis as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
param Type
Odds Ratio (OR)
param Value
3.499
statistical Method
Regression, Logistic
tested Non Inferiority
false
ci Lower Limit
3.096
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.336
group Description
CIN1/4 in previous cycle as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
param Type
Odds Ratio (OR)
param Value
4.064
statistical Method
Regression, Logistic
tested Non Inferiority
false
ci Lower Limit
1.175
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.033
group Description
Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.002
param Type
Odds Ratio (OR)
param Value
1.545
statistical Method
Regression, Logistic
tested Non Inferiority
false
ci Lower Limit
1.088
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.340
group Description
History of CIN Grade 4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.017
param Type
Odds Ratio (OR)
param Value
1.596
statistical Method
Regression, Logistic
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
0.424
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.821
group Description
GIS (1 vs. 0) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.002
param Type
Odds Ratio (OR)
param Value
0.590
statistical Method
Regression, Logistic
tested Non Inferiority
false
ci Lower Limit
0.489
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.859
group Description
Zarzio duration: 4-5 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.003
param Type
Odds Ratio (OR)
param Value
0.644
statistical Method
Regression, Logistic
tested Non Inferiority
false
ci Lower Limit
0.398
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.842
group Description
Zarzio duration: 1-3 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.004
param Type
Odds Ratio (OR)
param Value
0.579
statistical Method
Regression, Logistic
tested Non Inferiority
false
ci Lower Limit
1.140
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.643
group Description
ECOG score (per 1 point) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.001
param Type
Odds Ratio (OR)
param Value
1.369
statistical Method
Regression, Logistic
tested Non Inferiority
false
ci Lower Limit
2.456
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
4.985
group Description
Concomitant antibiotic prophylaxis as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
param Type
Odds Ratio (OR)
param Value
3.499
statistical Method
Regression, Logistic
tested Non Inferiority
false
ci Lower Limit
3.096
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.336
group Description
CIN1/4 in previous cycle as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
param Type
Odds Ratio (OR)
param Value
4.064
statistical Method
Regression, Logistic
tested Non Inferiority
false
ci Lower Limit
1.175
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.033
group Description
Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.002
param Type
Odds Ratio (OR)
param Value
1.545
statistical Method
Regression, Logistic
tested Non Inferiority
false
ci Lower Limit
1.088
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.340
group Description
History of CIN Grade 4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.017
param Type
Odds Ratio (OR)
param Value
1.596
statistical Method
Regression, Logistic
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
value
507

denom Units Selected

Participants

denoms

counts
group Id
OG000
value
1529
units
Participants
counts
group Id
OG000
value
5193
units
cycles

description

groups

description
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
id
OG000
title
EP2006

param Type

NUMBER

population Description

Cycles of patients from evaluable sample with composite outcome data

reporting Status

POSTED

time Frame

All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

title

Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Cycle Level

type

SECONDARY

type Units Analyzed

cycles

unit Of Measure

cycles

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Preserved source evidence · Not medical advice