NCT00999830 · OUTCOME

Safety Assessment

Evaluation of Activity, Safety and Pharmacology of IPH2101 a Human Monoclonal Antibody in Patients With Multiple Myeloma · Source last updated 2016-03-24

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: from screening visit to the End of Study (at each study visit)

What was measured

Adverse Events, Serious Adverse Events, physical examination and biological changes.

Groups in this outcome

Arm A: IPH2101 0.2mg/Kg

every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.

Arm B: IPH2101 2mg/kg

every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.

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
Arm A: IPH2101 0.2mg/Kg	14
Arm B: IPH2101 2mg/kg	13

Reported measurements

Source class 1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm A: IPH2101 0.2mg/Kg	14	Not reported	Not reported	Not reported	Not reported
Arm B: IPH2101 2mg/kg	11	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
14
group Id
OG001
value
11

denoms

counts
group Id
OG000
value
14
group Id
OG001
value
13
units
Participants

description

Adverse Events, Serious Adverse Events, physical examination and biological changes.

groups

description
every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
id
OG000
title
Arm A: IPH2101 0.2mg/Kg
description
every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
id
OG001
title
Arm B: IPH2101 2mg/kg

param Type

NUMBER

reporting Status

POSTED

time Frame

from screening visit to the End of Study (at each study visit)

title

Safety Assessment

type

SECONDARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice