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NCT01248455 · OUTCOME

Count of Participants With Serious and Non-Serious Adverse Events

A Phase II Trial of Anti-KIR in Smoldering Multiple Myeloma · Source last updated 2019-11-19

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
Date treatment consent signed to date off study, approximately 3 years and 5 months

What was measured

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Groups in this outcome

Anti-KIR in Smoldering Multiple Myeloma Patients

Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles (Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 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
Anti-KIR in Smoldering Multiple Myeloma Patients9

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Anti-KIR in Smoldering Multiple Myeloma Patients9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    units
    Participants
description
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
groups
  1. description
    Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles (Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
    id
    OG000
    title
    Anti-KIR in Smoldering Multiple Myeloma Patients
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Date treatment consent signed to date off study, approximately 3 years and 5 months
title
Count of Participants With Serious and Non-Serious Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice