Phase II - Occurrence of Possibly Related Adverse Events (AEs)
Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide · Source last updated 2017-05-23
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 48 Months
What was measured
Phase II: Participants with Grade 3 or 4 adverse events at least possibly related to the study treatment in 5% of participants in the Phase 2 portion, by AE category, assessed by the National Cancer Institute Common Terminology Criteria (NCI CTC) version 4.0.
Analysis population: All Phase II Participants who completed allocated intervention.
Groups in this outcome
B: Pomalidomide and Dexamethasone
Phase II: Pomalidomide and high dose dexamethasone.
Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
Arm D participants may be referenced separately in some Outcome Measures.
C: Pomalidomide, Dexamethasone, Cyclophosphamide
Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
D: Crossover Arm
Phase II: Participants who crossed over from Arm B to Arm D. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
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
B: Pomalidomide and Dexamethasone
35
C: Pomalidomide, Dexamethasone, Cyclophosphamide
33
D: Crossover Arm
17
Reported measurements
Anemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
11.4
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
24.2
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
5.9
Not reported
Not reported
Not reported
Not reported
Febrile neutropenia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
11.4
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
12.1
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
0
Not reported
Not reported
Not reported
Not reported
Fatigue
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
8.6
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
1.21
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
0
Not reported
Not reported
Not reported
Not reported
Flu-like symptoms
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
0
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
0
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
5.9
Not reported
Not reported
Not reported
Not reported
Lung infection
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
11.4
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
9.1
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
5.9
Not reported
Not reported
Not reported
Not reported
Sepsis
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
0
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
9.1
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
0
Not reported
Not reported
Not reported
Not reported
Upper respiratory infection
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
0
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
6.1
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
0
Not reported
Not reported
Not reported
Not reported
Lymphodemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
11.4
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
9.1
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
11.8
Not reported
Not reported
Not reported
Not reported
Neutropenia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
31.4
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
51.5
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
23.5
Not reported
Not reported
Not reported
Not reported
Thrombocytopenia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
5.7
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
15.2
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
0
Not reported
Not reported
Not reported
Not reported
Leukopenia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
14.3
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
12.1
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
5.9
Not reported
Not reported
Not reported
Not reported
Hyperglycemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
0
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
6.1
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
0
Not reported
Not reported
Not reported
Not reported
Hyponatremia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
0
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
6.1
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
0
Not reported
Not reported
Not reported
Not reported
Hypophosphatemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
0
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
0
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
5.9
Not reported
Not reported
Not reported
Not reported
Hypoxia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
0
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
0
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
5.9
Not reported
Not reported
Not reported
Not reported
Confusion
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
0
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
6.1
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
0
Not reported
Not reported
Not reported
Not reported
Pneumonitis
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
0
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
9.1
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
0
Not reported
Not reported
Not reported
Not reported
Thromboembolic event
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
B: Pomalidomide and Dexamethasone
0
Not reported
Not reported
Not reported
Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide
6.1
Not reported
Not reported
Not reported
Not reported
D: Crossover Arm
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
11.4
group Id
OG001
value
24.2
group Id
OG002
value
5.9
title
Anemia
categories
measurements
group Id
OG000
value
11.4
group Id
OG001
value
12.1
group Id
OG002
value
0
title
Febrile neutropenia
categories
measurements
group Id
OG000
value
8.6
group Id
OG001
value
1.21
group Id
OG002
value
0
title
Fatigue
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
5.9
title
Flu-like symptoms
categories
measurements
group Id
OG000
value
11.4
group Id
OG001
value
9.1
group Id
OG002
value
5.9
title
Lung infection
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
9.1
group Id
OG002
value
0
title
Sepsis
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
6.1
group Id
OG002
value
0
title
Upper respiratory infection
categories
measurements
group Id
OG000
value
11.4
group Id
OG001
value
9.1
group Id
OG002
value
11.8
title
Lymphodemia
categories
measurements
group Id
OG000
value
31.4
group Id
OG001
value
51.5
group Id
OG002
value
23.5
title
Neutropenia
categories
measurements
group Id
OG000
value
5.7
group Id
OG001
value
15.2
group Id
OG002
value
0
title
Thrombocytopenia
categories
measurements
group Id
OG000
value
14.3
group Id
OG001
value
12.1
group Id
OG002
value
5.9
title
Leukopenia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
6.1
group Id
OG002
value
0
title
Hyperglycemia
denoms
counts
group Id
OG000
value
35
group Id
OG001
value
33
group Id
OG002
value
17
units
Participants
description
Phase II: Participants with Grade 3 or 4 adverse events at least possibly related to the study treatment in 5% of participants in the Phase 2 portion, by AE category, assessed by the National Cancer Institute Common Terminology Criteria (NCI CTC) version 4.0.
groups
description
Phase II: Pomalidomide and high dose dexamethasone.
Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
Arm D participants may be referenced separately in some Outcome Measures.
id
OG000
title
B: Pomalidomide and Dexamethasone
description
Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
id
OG001
title
C: Pomalidomide, Dexamethasone, Cyclophosphamide
description
Phase II: Participants who crossed over from Arm B to Arm D. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
id
OG002
title
D: Crossover Arm
param Type
NUMBER
population Description
All Phase II Participants who completed allocated intervention.
reporting Status
POSTED
time Frame
Up to 48 Months
title
Phase II - Occurrence of Possibly Related Adverse Events (AEs)
Triangle