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NCT00622336 · OUTCOME

Number of Participants With Adverse Events (AE) During the Treatment 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
Until data cut-off of 22 Oct 2009; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Maximum exposure to Lenalidomide treatment was 1260 days.

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: 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)330

Reported measurements

Adverse Event (AE)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide 25mg (CC-5013)327Not reportedNot reportedNot reportedNot reported
Adverse Event related to study drug
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide 25mg (CC-5013)268Not 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)256Not reportedNot reportedNot reportedNot reported
Serious Adverse Event (SAE)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide 25mg (CC-5013)177Not reportedNot reportedNot reportedNot reported
AE leading to discontinuation of study drug
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide 25mg (CC-5013)52Not reportedNot reportedNot reportedNot reported
AE leading to dose reduction/interruption
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide 25mg (CC-5013)210Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        327
    title
    Adverse Event (AE)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        268
    title
    Adverse Event related to study drug
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        256
    title
    Adverse Event NCI CTC (Version2.0) Grade 3 or 4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        177
    title
    Serious Adverse Event (SAE)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        52
    title
    AE leading to discontinuation of study drug
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        210
    title
    AE leading to dose reduction/interruption
denoms
  1. counts
    1. group Id
      OG000
      value
      330
    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
The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.
reporting Status
POSTED
time Frame
Until data cut-off of 22 Oct 2009; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Maximum exposure to Lenalidomide treatment was 1260 days.
title
Number of Participants With Adverse Events (AE) During the Treatment Phase
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice