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NCT01169337 · OUTCOME

Proportion of Patients With Grade 3 Adverse Events That Effect Vital Organ Function or Any Grade 4 or Higher Non-hematologic Adverse Events (Phase II Primary Endpoint)

Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma · Source last updated 2026-08-04

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

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
90% Confidence Interval
Time frame
Assessed every 4 weeks while on treatment up to 24 weeks

What was measured

Proportion of patients with grade 3 adverse events that effect vital organ function (such as cardiac, hepatic or thromboembolic) or any grade 4 or higher non-hematologic adverse events

Analysis population: The first 36 patients in the phase II part as planned in the study design

Groups in this outcome

Arm A (Lenalidomide; Phase II)

Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Arm A (Lenalidomide; Phase II)36

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Lenalidomide; Phase II)0.056Not reported0.0100.165Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.010
        upper Limit
        0.165
        value
        0.056
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    units
    Participants
description
Proportion of patients with grade 3 adverse events that effect vital organ function (such as cardiac, hepatic or thromboembolic) or any grade 4 or higher non-hematologic adverse events
dispersion Type
90% Confidence Interval
groups
  1. description
    Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Arm A (Lenalidomide; Phase II)
param Type
NUMBER
population Description
The first 36 patients in the phase II part as planned in the study design
reporting Status
POSTED
time Frame
Assessed every 4 weeks while on treatment up to 24 weeks
title
Proportion of Patients With Grade 3 Adverse Events That Effect Vital Organ Function or Any Grade 4 or Higher Non-hematologic Adverse Events (Phase II Primary Endpoint)
type
PRIMARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice