NCT02041325 · OUTCOME

Safety

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.

What was measured

Number of participants with adverse events as a measure of safety and tolerability

Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.

Subjects will receive placebo 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

Source class 1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide	2	Not reported	Not reported	Not reported	Not reported
Placebo	2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

denoms

description

Number of participants with adverse events as a measure of safety and tolerability

groups

param Type

NUMBER

reporting Status

POSTED

time Frame

6 weeks

title

Safety

type

SECONDARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice