NCT02041325 · OUTCOME

Positive for Hepatitis B Surface Antigen

Investigation of the Enhancement of Response to Hepatitis B Vaccine by Lenalidomide in Plasma Cell Dyscrasias · Source last updated 2016-05-17

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

Measure: NUMBER
Unit: participants
Interval / dispersion: Not reported
Time frame: 6 weeks

What was measured

The number of participants who test positive for the antibody titer against hepatitis B surface antigen (HbSAg).

Groups in this outcome

Lenalidomide

Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks. Lenalidomide: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks.

Placebo

Placebo will be administered for 7 days prior to and 7 days after the vaccine. Placebo: Placebo will be administered for 7 days prior to and 7 days after the vaccine.

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
Lenalidomide	22
Placebo	16

Reported measurements

Source class 1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide	4	Not reported	Not reported	Not reported	Not reported
Placebo	3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
4
group Id
OG001
value
3

denoms

counts
group Id
OG000
value
22
group Id
OG001
value
16
units
Participants

description

The number of participants who test positive for the antibody titer against hepatitis B surface antigen (HbSAg).

groups

description
Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks. Lenalidomide: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks.
id
OG000
title
Lenalidomide
description
Placebo will be administered for 7 days prior to and 7 days after the vaccine. Placebo: Placebo will be administered for 7 days prior to and 7 days after the vaccine.
id
OG001
title
Placebo

param Type

NUMBER

reporting Status

POSTED

time Frame

6 weeks

title

Positive for Hepatitis B Surface Antigen

type

PRIMARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice