NCT00833833 · OUTCOME

Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Pomalidomide and Dexamethasone as of the 01 April 2011 Cut-off

MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma · Source last updated 2016-04-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Up to week 126

What was measured

TEAEs that occurred during Phase 1 after dexamethasone was added to pomalidomide treatment. 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 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are 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. Data collection is ongoing and future data results will be included as available.

Analysis population: Safety population. Data collection is ongoing and future data results will be included as available.

Groups in this outcome

Phase 1: 2 mg Pomalidomide

Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.

Phase 1: 3 mg Pomalidomide

Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.

Phase 1: 4 mg Pomalidomide

Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.

Phase 1: 5 mg Pomalidomide

Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.

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
Phase 1: 2 mg Pomalidomide	1
Phase 1: 3 mg Pomalidomide	4
Phase 1: 4 mg Pomalidomide	10
Phase 1: 5 mg Pomalidomide	7

Reported measurements

1 or more (1+) AE

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: 2 mg Pomalidomide	100.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 3 mg Pomalidomide	100.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 4 mg Pomalidomide	90.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 5 mg Pomalidomide	100.0	Not reported	Not reported	Not reported	Not reported

1+ AE related to pomalidomide

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: 2 mg Pomalidomide	100.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 3 mg Pomalidomide	75.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 4 mg Pomalidomide	80.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 5 mg Pomalidomide	100.0	Not reported	Not reported	Not reported	Not reported

1+ AE related to dexamethasone

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: 2 mg Pomalidomide	100.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 3 mg Pomalidomide	75.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 4 mg Pomalidomide	70.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 5 mg Pomalidomide	85.7	Not reported	Not reported	Not reported	Not reported

1+ severity grade 3-4 AE

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: 2 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 3 mg Pomalidomide	75.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 4 mg Pomalidomide	70.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 5 mg Pomalidomide	57.1	Not reported	Not reported	Not reported	Not reported

1+ severity grade 3-4 AE related to pomalidomide

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: 2 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 3 mg Pomalidomide	75.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 4 mg Pomalidomide	20.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 5 mg Pomalidomide	42.9	Not reported	Not reported	Not reported	Not reported

1+ severity grade 3-4 AE related to dexamethasone

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: 2 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 3 mg Pomalidomide	75.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 4 mg Pomalidomide	20.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 5 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported

1+ serious AE (SAE)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: 2 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 3 mg Pomalidomide	75.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 4 mg Pomalidomide	40.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 5 mg Pomalidomide	28.6	Not reported	Not reported	Not reported	Not reported

1+ SAE related to pomalidomide

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: 2 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 3 mg Pomalidomide	25.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 4 mg Pomalidomide	20.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 5 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported

1+ SAE related to dexamethasone

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: 2 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 3 mg Pomalidomide	50.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 4 mg Pomalidomide	10.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 5 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported

1+ AE leading to discontinuation of pomalidomide

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: 2 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 3 mg Pomalidomide	25.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 4 mg Pomalidomide	20.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 5 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported

1+ AE -- discontinuation of dexamethasone

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: 2 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 3 mg Pomalidomide	25.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 4 mg Pomalidomide	20.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 5 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported

1+AE -dose reduction/interruption of pomalidomide

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: 2 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 3 mg Pomalidomide	50.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 4 mg Pomalidomide	40.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 5 mg Pomalidomide	71.4	Not reported	Not reported	Not reported	Not reported

1+ AE-dose reduction/interruption of dexamethasone

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: 2 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 3 mg Pomalidomide	75.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 4 mg Pomalidomide	60.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 5 mg Pomalidomide	71.4	Not reported	Not reported	Not reported	Not reported

1+related AE-reduction/interruption of pomalidomid

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: 2 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 3 mg Pomalidomide	25.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 4 mg Pomalidomide	20.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 5 mg Pomalidomide	57.1	Not reported	Not reported	Not reported	Not reported

1+related AE-reduction/interruption of dexamethaso

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: 2 mg Pomalidomide	0.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 3 mg Pomalidomide	75.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 4 mg Pomalidomide	20.0	Not reported	Not reported	Not reported	Not reported
Phase 1: 5 mg Pomalidomide	42.9	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
100.0
group Id
OG001
value
100.0
group Id
OG002
value
90.0
group Id
OG003
value
100.0
title
1 or more (1+) AE
categories
measurements
group Id
OG000
value
100.0
group Id
OG001
value
75.0
group Id
OG002
value
80.0
group Id
OG003
value
100.0
title
1+ AE related to pomalidomide
categories
measurements
group Id
OG000
value
100.0
group Id
OG001
value
75.0
group Id
OG002
value
70.0
group Id
OG003
value
85.7
title
1+ AE related to dexamethasone
categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
75.0
group Id
OG002
value
70.0
group Id
OG003
value
57.1
title
1+ severity grade 3-4 AE
categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
75.0
group Id
OG002
value
20.0
group Id
OG003
value
42.9
title
1+ severity grade 3-4 AE related to pomalidomide
categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
75.0
group Id
OG002
value
20.0
group Id
OG003
value
0.0
title
1+ severity grade 3-4 AE related to dexamethasone
categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
75.0
group Id
OG002
value
40.0
group Id
OG003
value
28.6
title
1+ serious AE (SAE)
categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
25.0
group Id
OG002
value
20.0
group Id
OG003
value
0.0
title
1+ SAE related to pomalidomide
categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
50.0
group Id
OG002
value
10.0
group Id
OG003
value
0.0
title
1+ SAE related to dexamethasone
categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
25.0
group Id
OG002
value
20.0
group Id
OG003
value
0.0
title
1+ AE leading to discontinuation of pomalidomide
categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
25.0
group Id
OG002
value
20.0
group Id
OG003
value
0.0
title
1+ AE -- discontinuation of dexamethasone
categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
50.0
group Id
OG002
value
40.0
group Id
OG003
value
71.4
title
1+AE -dose reduction/interruption of pomalidomide

denoms

counts
group Id
OG000
value
1
group Id
OG001
value
4
group Id
OG002
value
10
group Id
OG003
value
7
units
Participants

description

groups

description
Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
id
OG000
title
Phase 1: 2 mg Pomalidomide
description
Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
id
OG001
title
Phase 1: 3 mg Pomalidomide
description
Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
id
OG002
title
Phase 1: 4 mg Pomalidomide
description
Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
id
OG003
title
Phase 1: 5 mg Pomalidomide

param Type

NUMBER

population Description

Safety population. Data collection is ongoing and future data results will be included as available.

reporting Status

POSTED

time Frame

Up to week 126

title

Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Pomalidomide and Dexamethasone as of the 01 April 2011 Cut-off

type

SECONDARY

unit Of Measure

percentage of participants

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