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NCT01222286 · OUTCOME

Safety Assessment

Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma · Source last updated 2026-05-14

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

Measure
NUMBER
Unit
Patients with any AE
Interval / dispersion
Not reported
Time frame
Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months

What was measured

adverse events, physical examination and biological changes during the whole clinical trial.

Analysis population: The safety population included all subjects who received at least 1 dose of IPH2101

Groups in this outcome

IPH2101 0.2 mg/kg

0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles

IPH2101 2 mg/kg

2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
IPH2101 0.2 mg/kg16
IPH2101 2 mg/kg14

Reported measurements

Source class 1
Values in Patients with any AE · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IPH2101 0.2 mg/kg16Not reportedNot reportedNot reportedNot reported
IPH2101 2 mg/kg14Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        14
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      14
    units
    Participants
description
adverse events, physical examination and biological changes during the whole clinical trial.
groups
  1. description
    0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
    id
    OG000
    title
    IPH2101 0.2 mg/kg
  2. description
    2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
    id
    OG001
    title
    IPH2101 2 mg/kg
param Type
NUMBER
population Description
The safety population included all subjects who received at least 1 dose of IPH2101
reporting Status
POSTED
time Frame
Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
title
Safety Assessment
type
SECONDARY
unit Of Measure
Patients with any AE

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

Preserved source evidence · Not medical advice