NCT01611090 · OUTCOME

Change From Baseline in Beta2 Microglobulin at End of Treatment (EOT)

A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma · Source last updated 2020-03-03

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

Measure: MEAN
Unit: milligram per liter (mg/L)
Interval / dispersion: Standard Deviation
Time frame: Baseline to EOT (Up to 2 years)

What was measured

Change from baseline in beta2 microglobulin at end of treatment at time of primary analysis was reported.

Analysis population: ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint.

Groups in this outcome

Ibrutinib+BR

Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.

Placebo+BR

Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.

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
Ibrutinib+BR	39
Placebo+BR	106

Reported measurements

Source class 1

Values in milligram per liter (mg/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ibrutinib+BR	-0.46	1.77	Not reported	Not reported	Not reported
Placebo+BR	-0.23	2.08	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
1.77
value
-0.46
group Id
OG001
spread
2.08
value
-0.23

denoms

counts
group Id
OG000
value
39
group Id
OG001
value
106
units
Participants

description

Change from baseline in beta2 microglobulin at end of treatment at time of primary analysis was reported.

dispersion Type

Standard Deviation

groups

description
Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.
id
OG000
title
Ibrutinib+BR
description
Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
id
OG001
title
Placebo+BR

param Type

MEAN

population Description

ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint.

reporting Status

POSTED

time Frame

Baseline to EOT (Up to 2 years)

title

Change From Baseline in Beta2 Microglobulin at End of Treatment (EOT)

type

SECONDARY

unit Of Measure

milligram per liter (mg/L)

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

Preserved source evidence · Not medical advice