Number of Participants With Treatment Emergent Adverse Events (TEAE)
Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma · Source last updated 2022-01-10
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
From the first dose of study treatment up to 28 days following the last dose of study treatment. The median duration of treatment with pomalidomide and LD-dex was 21.4 weeks.
What was measured
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, regardless of etiology. Any worsening (i.e., any significant adverse change in the frequency or intensity of a pre- existing condition) was considered an AE. The severity of AEs were graded based on the symptoms according to version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events. Second primary malignancies were monitored as events of interest and considered as part of the assessment of AEs.
A SAE = AE occurring at any dose that:
* 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
Analysis population: The safety population includes all enrolled participants who received at least one dose of the IP.
Groups in this outcome
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.
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 Plus Low Dose Dexamethasone (LD-Dex)
676
Reported measurements
≥ TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
673
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE Related to Pomalidomide (POM)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
527
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE Related to LD-Dex
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
448
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE Related to Either POM or LD-Dex
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
575
Not reported
Not reported
Not reported
Not reported
≥ 1 Grade (Gr) 3 or 4 TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
606
Not reported
Not reported
Not reported
Not reported
≥ 1 Gr 3 or 4 TEAE Related to (R/T) POM
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
417
Not reported
Not reported
Not reported
Not reported
≥ 1 Gr 3 or 4 TEAE R/T LD-Dex
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
226
Not reported
Not reported
Not reported
Not reported
≥ 1 Gr 3 or 4 TEAE R/T Either POM or LD-Dex
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
448
Not reported
Not reported
Not reported
Not reported
≥ 1 Grade 5 TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
127
Not reported
Not reported
Not reported
Not reported
≥ 1 Grade 5 TEAE R/T POM
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
14
Not reported
Not reported
Not reported
Not reported
≥ 1 Grade 5 TEAE R/T LD-Dex
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
16
Not reported
Not reported
Not reported
Not reported
≥ 1 Grade 5 TEAE R/T either POM or LD-Dex
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
18
Not reported
Not reported
Not reported
Not reported
≥ 1 Serious TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
448
Not reported
Not reported
Not reported
Not reported
≥ 1 Serious TEAE R/T POM
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
187
Not reported
Not reported
Not reported
Not reported
≥ 1 Serious TEAE R/T LD-Dex
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
146
Not reported
Not reported
Not reported
Not reported
≥ 1 Serious TEAE R/T Either POM or LD-Dex
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
215
Not reported
Not reported
Not reported
Not reported
≥ 1 Serious TEAE Leading to (L/T)Stopping of POM
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
36
Not reported
Not reported
Not reported
Not reported
≥ 1 Serious TEAE L/T Stopping of LD-Dex
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
34
Not reported
Not reported
Not reported
Not reported
≥1 Serious TEAE L/T Stopping either POM or LD-Dex
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
37
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE L/T to Stopping of POM
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
54
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE L/T to Stopping of LD-DEX
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
61
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE L/T to Stopping of Either POM or LD-DEX
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
63
Not reported
Not reported
Not reported
Not reported
≥1 Study Drug Related TEAE (L/T) Stopping POM
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
30
Not reported
Not reported
Not reported
Not reported
≥1 Study Drug Related TEAE L/T Stopping LD-Dex
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
19
Not reported
Not reported
Not reported
Not reported
≥1 Drug Related TEAE L/T Stopping LD-Dex or POM
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
38
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE L/T to Reduction (R/D) of POM
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
164
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE L/T to R/D of LD-DEX
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
150
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE L/T to R/D of Either POM or LD-DEX
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
244
Not reported
Not reported
Not reported
Not reported
≥ 1 Study Drug Related TEAE L/T to R/D of POM
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
142
Not reported
Not reported
Not reported
Not reported
≥ 1 Study Drug Related TEAE L/T to R/D of LD-DEX
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
135
Not reported
Not reported
Not reported
Not reported
≥1 StudyDrug Related TEAE L/T to R/D POM or LD-DEX
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
224
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE L/T to Interruption (I/R) of POM
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
455
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE L/T to I/R of LD-DEX
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
434
Not reported
Not reported
Not reported
Not reported
≥ 1 TEAE L/T to I/R of either POM or LD-DEX
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
470
Not reported
Not reported
Not reported
Not reported
≥ 1 Study Drug Related TEAE L/T to I/R of POM
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
294
Not reported
Not reported
Not reported
Not reported
≥ 1 Study Drug Related TEAE L/T to I/R of LD-DEX
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
185
Not reported
Not reported
Not reported
Not reported
≥1 StudyDrug Related TEAE L/T to I/R POM or LD-DEX
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
333
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
673
title
≥ TEAE
categories
measurements
group Id
OG000
value
527
title
≥ 1 TEAE Related to Pomalidomide (POM)
categories
measurements
group Id
OG000
value
448
title
≥ 1 TEAE Related to LD-Dex
categories
measurements
group Id
OG000
value
575
title
≥ 1 TEAE Related to Either POM or LD-Dex
categories
measurements
group Id
OG000
value
606
title
≥ 1 Grade (Gr) 3 or 4 TEAE
categories
measurements
group Id
OG000
value
417
title
≥ 1 Gr 3 or 4 TEAE Related to (R/T) POM
categories
measurements
group Id
OG000
value
226
title
≥ 1 Gr 3 or 4 TEAE R/T LD-Dex
categories
measurements
group Id
OG000
value
448
title
≥ 1 Gr 3 or 4 TEAE R/T Either POM or LD-Dex
categories
measurements
group Id
OG000
value
127
title
≥ 1 Grade 5 TEAE
categories
measurements
group Id
OG000
value
14
title
≥ 1 Grade 5 TEAE R/T POM
categories
measurements
group Id
OG000
value
16
title
≥ 1 Grade 5 TEAE R/T LD-Dex
categories
measurements
group Id
OG000
value
18
title
≥ 1 Grade 5 TEAE R/T either POM or LD-Dex
denoms
counts
group Id
OG000
value
676
units
Participants
description
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, regardless of etiology. Any worsening (i.e., any significant adverse change in the frequency or intensity of a pre- existing condition) was considered an AE. The severity of AEs were graded based on the symptoms according to version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events. Second primary malignancies were monitored as events of interest and considered as part of the assessment of AEs.
A SAE = AE occurring at any dose that:
* 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
groups
description
Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.
id
OG000
title
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety population includes all enrolled participants who received at least one dose of the IP.
reporting Status
POSTED
time Frame
From the first dose of study treatment up to 28 days following the last dose of study treatment. The median duration of treatment with pomalidomide and LD-dex was 21.4 weeks.
title
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Triangle