NCT01109069 · OUTCOME

Documented Responses

Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia · Source last updated 2020-05-27

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 30 days after last dose of study drug, continue up to 6 months

What was measured

Investigator-assessed responses were summarized descriptively for subjects with CLL/SLL and listed for subjects with other NHLs based on the efficacy population.

Groups in this outcome

IBRUTINIB/PCI-32765

This was a multicenter, open-label, monotherapy, long-term extension study designed to evaluate the long-term (\> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. PCI-32765: Dose based on parent protocol CLL: chronic lymphocytic leukemia/ SLL: small lymphocytic lymphoma.

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/PCI-32765	199

Reported measurements

Source class 1

CLL/SLL

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
IBRUTINIB/PCI-32765	180	Not reported	Not reported	Not reported	Not reported

Other NHL

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
IBRUTINIB/PCI-32765	16	Not reported	Not reported	Not reported	Not reported

Treatment discontinuation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
IBRUTINIB/PCI-32765	3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
180
title
CLL/SLL
measurements
group Id
OG000
value
16
title
Other NHL
measurements
group Id
OG000
value
3
title
Treatment discontinuation

denoms

counts
group Id
OG000
value
199
units
Participants

description

Investigator-assessed responses were summarized descriptively for subjects with CLL/SLL and listed for subjects with other NHLs based on the efficacy population.

groups

description
This was a multicenter, open-label, monotherapy, long-term extension study designed to evaluate the long-term (\> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. PCI-32765: Dose based on parent protocol CLL: chronic lymphocytic leukemia/ SLL: small lymphocytic lymphoma.
id
OG000
title
IBRUTINIB/PCI-32765

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

30 days after last dose of study drug, continue up to 6 months

title

Documented Responses

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice