Number of Participants With Adverse Events and Type of Adverse Events
Study to Evaluate the Safety and Efficacy of Pomalidomide Monotherapy in Subjects With Refractory or Relapsed Refractory 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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
What was measured
An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that:
* Results in death;
* Is life-threatening;
* Requires or prolongs existing inpatient hospitalization;
* Results in persistent or significant disability/incapacity;
* Is a congenital anomaly/birth defect;
* Constitutes an important medical event.
The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0):
Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death
Analysis population: Safety population includes all participants who received at least one dose of study drug.
Groups in this outcome
Pomalidomide
Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) 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
Group
Source count
Pomalidomide
73
Reported measurements
Any adverse event
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide
73
Not reported
Not reported
Not reported
Not reported
Grade 3-4 adverse event
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide
64
Not reported
Not reported
Not reported
Not reported
AE related to pomalidomide
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide
51
Not reported
Not reported
Not reported
Not reported
Grade 3-4 AE related to pomalidomide
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide
33
Not reported
Not reported
Not reported
Not reported
Grade 5 AE
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide
19
Not reported
Not reported
Not reported
Not reported
≥1 Serious AE (SAE)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide
52
Not reported
Not reported
Not reported
Not reported
≥1 SAE related to pomalidomide
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide
15
Not reported
Not reported
Not reported
Not reported
≥1 SAE leading to stopping pomalidomide
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide
6
Not reported
Not reported
Not reported
Not reported
≥AE leading to discontinuation of pomalidomide
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide
8
Not reported
Not reported
Not reported
Not reported
≥1 study drug related AE leading to stopping POM
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide
1
Not reported
Not reported
Not reported
Not reported
≥1 AE leading to reduction of pomalidomide
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide
11
Not reported
Not reported
Not reported
Not reported
≥1 study drug related AE leading to reducing POM
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide
9
Not reported
Not reported
Not reported
Not reported
≥1 AE leading to interruption of pomalidomide
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide
41
Not reported
Not reported
Not reported
Not reported
≥ 1 study drug related interruption of POM
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide
25
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
73
title
Any adverse event
categories
measurements
group Id
OG000
value
64
title
Grade 3-4 adverse event
categories
measurements
group Id
OG000
value
51
title
AE related to pomalidomide
categories
measurements
group Id
OG000
value
33
title
Grade 3-4 AE related to pomalidomide
categories
measurements
group Id
OG000
value
19
title
Grade 5 AE
categories
measurements
group Id
OG000
value
52
title
≥1 Serious AE (SAE)
categories
measurements
group Id
OG000
value
15
title
≥1 SAE related to pomalidomide
categories
measurements
group Id
OG000
value
6
title
≥1 SAE leading to stopping pomalidomide
categories
measurements
group Id
OG000
value
8
title
≥AE leading to discontinuation of pomalidomide
categories
measurements
group Id
OG000
value
1
title
≥1 study drug related AE leading to stopping POM
categories
measurements
group Id
OG000
value
11
title
≥1 AE leading to reduction of pomalidomide
categories
measurements
group Id
OG000
value
9
title
≥1 study drug related AE leading to reducing POM
denoms
counts
group Id
OG000
value
73
units
Participants
description
An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that:
* Results in death;
* Is life-threatening;
* Requires or prolongs existing inpatient hospitalization;
* Results in persistent or significant disability/incapacity;
* Is a congenital anomaly/birth defect;
* Constitutes an important medical event.
The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0):
Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death
groups
description
Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
id
OG000
title
Pomalidomide
param Type
NUMBER
population Description
Safety population includes all participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
title
Number of Participants With Adverse Events and Type of Adverse Events
Triangle