Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00622336 · OUTCOME

Number of Participants With Adverse Events (AE) During the Extension Phase

A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma · Source last updated 2019-11-20

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 22 Oct 2009 to November 2013; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit.

What was measured

An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;

Analysis population: Included participants who were enrolled in the extension phase. The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.

Groups in this outcome

Lenalidomide 25mg (CC-5013)

Oral 25mg daily on Days 1-21 every 28 days

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

Analysis denominator · Participants

GroupSource count
Lenalidomide 25mg (CC-5013)21

Reported measurements

≥ 1 Adverse Event (AE)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide 25mg (CC-5013)13Not reportedNot reportedNot reportedNot reported
Adverse Event related to study drug
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide 25mg (CC-5013)1Not reportedNot reportedNot reportedNot reported
Adverse Event NCI CTC (Version2.0) Grade 3 or 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide 25mg (CC-5013)5Not reportedNot reportedNot reportedNot reported
≥ 1 Serious Adverse Event (SAE)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide 25mg (CC-5013)5Not reportedNot reportedNot reportedNot reported
≥ 1 AE leading to discontinuation of study drug
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide 25mg (CC-5013)1Not reportedNot reportedNot reportedNot reported
≥ 1 AE leading to dose reduction/interruption
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide 25mg (CC-5013)3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    ≥ 1 Adverse Event (AE)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Adverse Event related to study drug
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Adverse Event NCI CTC (Version2.0) Grade 3 or 4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    ≥ 1 Serious Adverse Event (SAE)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    ≥ 1 AE leading to discontinuation of study drug
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    ≥ 1 AE leading to dose reduction/interruption
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;
groups
  1. description
    Oral 25mg daily on Days 1-21 every 28 days
    id
    OG000
    title
    Lenalidomide 25mg (CC-5013)
param Type
NUMBER
population Description
Included participants who were enrolled in the extension phase. The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.
reporting Status
POSTED
time Frame
From 22 Oct 2009 to November 2013; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit.
title
Number of Participants With Adverse Events (AE) During the Extension Phase
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice