Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
SMAC Mimetic LCL161 Alone or With Cyclophosphamide in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2019-09-10
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
Up to 30 days after the last day of study drug treatment
What was measured
The maximum grade for each type of adverse event, regardless of causality, will be recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event are reported below.
Groups in this outcome
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression 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
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
25
Reported measurements
Anemia
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
24
Not reported
Not reported
Not reported
Not reported
Fatigue
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
16
Not reported
Not reported
Not reported
Not reported
Nausea
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
4.0
Not reported
Not reported
Not reported
Not reported
Platelet count decreased
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
12.0
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
36.0
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
52.0
Not reported
Not reported
Not reported
Not reported
Vomiting
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
4.0
Not reported
Not reported
Not reported
Not reported
White blood cell decreased
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
20.0
Not reported
Not reported
Not reported
Not reported
Diarrhea
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
4.0
Not reported
Not reported
Not reported
Not reported
Rash maculo-papular
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
4.0
Not reported
Not reported
Not reported
Not reported
Hyperglycemia
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
12.0
Not reported
Not reported
Not reported
Not reported
Lymphocyte count increased
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
8
Not reported
Not reported
Not reported
Not reported
Syncope
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
12.0
Not reported
Not reported
Not reported
Not reported
Hyperuricemia
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
4.0
Not reported
Not reported
Not reported
Not reported
Hypotension
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
4.0
Not reported
Not reported
Not reported
Not reported
Lung infection
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
4.0
Not reported
Not reported
Not reported
Not reported
Pain in extremity
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
4.0
Not reported
Not reported
Not reported
Not reported
Sepsis
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
4.0
Not reported
Not reported
Not reported
Not reported
Uriticaria
Values in percentage of patients · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
4.0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
24
title
Anemia
categories
measurements
group Id
OG000
value
16
title
Fatigue
categories
measurements
group Id
OG000
value
4.0
title
Nausea
categories
measurements
group Id
OG000
value
12.0
title
Platelet count decreased
categories
measurements
group Id
OG000
value
36.0
title
Neutrophil count decreased
categories
measurements
group Id
OG000
value
52.0
title
Lymphocyte count decreased
categories
measurements
group Id
OG000
value
4.0
title
Vomiting
categories
measurements
group Id
OG000
value
20.0
title
White blood cell decreased
categories
measurements
group Id
OG000
value
4.0
title
Diarrhea
categories
measurements
group Id
OG000
value
4.0
title
Rash maculo-papular
categories
measurements
group Id
OG000
value
12.0
title
Hyperglycemia
categories
measurements
group Id
OG000
value
8
title
Lymphocyte count increased
denoms
counts
group Id
OG000
value
25
units
Participants
description
The maximum grade for each type of adverse event, regardless of causality, will be recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event are reported below.
groups
description
Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
OG000
title
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 30 days after the last day of study drug treatment
title
Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Triangle