NCT00878709 · OUTCOME

Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2

Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer · Source last updated 2021-06-11

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: From randomization until time of event up to 2 years

What was measured

Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988).

Analysis population: Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.

Groups in this outcome

Neratinib

Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.

Placebo

Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.

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
Neratinib	1420
Placebo	1420

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Neratinib	0.92	Not reported	0.49	1.59	Not reported
Placebo	1.16	Not reported	0.68	1.87	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.49
upper Limit
1.59
value
0.92
group Id
OG001
lower Limit
0.68
upper Limit
1.87
value
1.16

denoms

counts
group Id
OG000
value
1420
group Id
OG001
value
1420
units
Participants

description

Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988).

dispersion Type

95% Confidence Interval

groups

description
Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
id
OG000
title
Neratinib
description
Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
id
OG001
title
Placebo

param Type

NUMBER

population Description

Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.

reporting Status

POSTED

time Frame

From randomization until time of event up to 2 years

title

Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2

type

SECONDARY

unit Of Measure

percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice