Japanese Phase 2 Study to Evaluate the Efficacy and Safety of Pomalidomide in Subjects With Relapsed and Refractory Multiple Myeloma · Source last updated 2016-11-01
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 to final data cut-off date of 25 Sept 2015, maximum duration on treatment was 80.9 weeks
What was measured
Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the first treatment of the study medication and within 28 days after the last dose.
Analysis population: Safety population includes all participants who took at least one dose of study medication.
Groups in this outcome
Pomalidomide Plus Dexamethasone
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.
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 Dexamethasone
36
Reported measurements
Any 1 TEAE
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
36
Not reported
Not reported
Not reported
Not reported
TEAE related to any study drugs
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
33
Not reported
Not reported
Not reported
Not reported
TEAE related to Pomalidomide
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
33
Not reported
Not reported
Not reported
Not reported
TEAE related to Dexamethasone(Dex)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
27
Not reported
Not reported
Not reported
Not reported
TEAE with ≥ Grade (GR) 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
33
Not reported
Not reported
Not reported
Not reported
≥ 1TEAE ≥ GR 3 related to any study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
30
Not reported
Not reported
Not reported
Not reported
TEAE ≥ GR 3 related to Pomalidomide
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
30
Not reported
Not reported
Not reported
Not reported
TEAE ≥ GR 3 related to Dexamethasone
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
11
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 Dexamethasone
16
Not reported
Not reported
Not reported
Not reported
Serious TEAE related to any study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
8
Not reported
Not reported
Not reported
Not reported
Serious TEAE related to Pomalidomide
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
8
Not reported
Not reported
Not reported
Not reported
Serious TEAE related to Dexamethasone
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
6
Not reported
Not reported
Not reported
Not reported
TEAE leading to stopping of any study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
5
Not reported
Not reported
Not reported
Not reported
TEAE leading to discontinuation of Pomalidomide
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
5
Not reported
Not reported
Not reported
Not reported
TEAE leading to discontinuation of Dexamethasone
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
5
Not reported
Not reported
Not reported
Not reported
Related TEAE leading to stopping of study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
4
Not reported
Not reported
Not reported
Not reported
Related TEAE leading to stopping of Pomalidomide
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
4
Not reported
Not reported
Not reported
Not reported
Related TEAE leading to stopping Dexamethasone
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
4
Not reported
Not reported
Not reported
Not reported
TEAE leading to dose reduction of any study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
19
Not reported
Not reported
Not reported
Not reported
TEAE leading to dose reduction of Pomalidomide
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
10
Not reported
Not reported
Not reported
Not reported
TEAE leading to dose reduction of Dexamethasone
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
15
Not reported
Not reported
Not reported
Not reported
TEA leading to dose interruption of any study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
20
Not reported
Not reported
Not reported
Not reported
TEAE leading to dose interruption of Pomalidomide
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
18
Not reported
Not reported
Not reported
Not reported
TEAE leading to dose interruption of Dexamethasone
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
11
Not reported
Not reported
Not reported
Not reported
Related TEAE leading to dose reduction of any drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
18
Not reported
Not reported
Not reported
Not reported
Related TEAE causing a dose reduction Pomalidomide
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
10
Not reported
Not reported
Not reported
Not reported
≥1 related TEAE causing a dose reduction: Dex
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
14
Not reported
Not reported
Not reported
Not reported
Related TEAE leading to interruption of drugs
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
16
Not reported
Not reported
Not reported
Not reported
Related TEAE causing an interruption Pomalidomide
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
15
Not reported
Not reported
Not reported
Not reported
Related TEAE causing an interruption to Dex
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
8
Not reported
Not reported
Not reported
Not reported
TEAE Grade 5
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide Plus Dexamethasone
3
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
36
title
Any 1 TEAE
categories
measurements
group Id
OG000
value
33
title
TEAE related to any study drugs
categories
measurements
group Id
OG000
value
33
title
TEAE related to Pomalidomide
categories
measurements
group Id
OG000
value
27
title
TEAE related to Dexamethasone(Dex)
categories
measurements
group Id
OG000
value
33
title
TEAE with ≥ Grade (GR) 3
categories
measurements
group Id
OG000
value
30
title
≥ 1TEAE ≥ GR 3 related to any study drug
categories
measurements
group Id
OG000
value
30
title
TEAE ≥ GR 3 related to Pomalidomide
categories
measurements
group Id
OG000
value
11
title
TEAE ≥ GR 3 related to Dexamethasone
categories
measurements
group Id
OG000
value
16
title
≥ 1 serious TEAE
categories
measurements
group Id
OG000
value
8
title
Serious TEAE related to any study drug
categories
measurements
group Id
OG000
value
8
title
Serious TEAE related to Pomalidomide
categories
measurements
group Id
OG000
value
6
title
Serious TEAE related to Dexamethasone
denoms
counts
group Id
OG000
value
36
units
Participants
description
Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the first treatment of the study medication and within 28 days after the last dose.
groups
description
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.
id
OG000
title
Pomalidomide Plus Dexamethasone
param Type
NUMBER
population Description
Safety population includes all participants who took at least one dose of study medication.
reporting Status
POSTED
time Frame
From first dose of study drug to final data cut-off date of 25 Sept 2015, maximum duration on treatment was 80.9 weeks
Triangle