Summary of All Adverse Events by Frequency in Greater Than 20% of Treated Participants
A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma · Source last updated 2020-03-18
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
From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months
What was measured
An adverse event (AE) was any medical occurrence in a participant who was administered denileukin diftitox and cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), and did not necessarily have a causal relationship with this treatment. An AE included any side effect, injury, toxicity, sensitivity reaction, or any undesirable clinical or laboratory event that was not normally observed in the participant. Safety was assessed for all participants who received at least one dose of study medication and was monitored throughout the study. Safety evaluations were based on the incidence, intensity, and type of AE, and clinically significant changes in the participant's medical history, physical examination findings, vital signs, and clinical laboratory results. Participants also notified the study staff of any problems that occurred between visits by telephone, and if necessary, were evaluated by the investigator or study staff at an unscheduled interim visit.
Analysis population: The Safety Population was used and defined as all treated participants. Participants who did not receive at least one dose of study medication were excluded from this population. For this study, the safety population is the same as the Intent to Treat (ITT) population.
Groups in this outcome
Denileukin Diftitox in Combination With CHOP
Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.
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
Denileukin Diftitox in Combination With CHOP
49
Reported measurements
Fatigue
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
63.3
Not reported
Not reported
Not reported
Not reported
Nausea
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
46.9
Not reported
Not reported
Not reported
Not reported
Hemoglobin
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
40.8
Not reported
Not reported
Not reported
Not reported
Neuropathy-sensory
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
40.8
Not reported
Not reported
Not reported
Not reported
Alanine transaminase
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
34.7
Not reported
Not reported
Not reported
Not reported
Hyperglycemia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
34.7
Not reported
Not reported
Not reported
Not reported
Hypoalbuminemia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
34.7
Not reported
Not reported
Not reported
Not reported
Leukocytes
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
34.7
Not reported
Not reported
Not reported
Not reported
Fever
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
32.7
Not reported
Not reported
Not reported
Not reported
Hypocalcemia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
30.6
Not reported
Not reported
Not reported
Not reported
Lymphopenia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
30.6
Not reported
Not reported
Not reported
Not reported
Aspartate transaminase
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
28.6
Not reported
Not reported
Not reported
Not reported
Dyspnea
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
28.6
Not reported
Not reported
Not reported
Not reported
Platelets
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
28.6
Not reported
Not reported
Not reported
Not reported
Alopecia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
26.5
Not reported
Not reported
Not reported
Not reported
Neutrophils
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
26.5
Not reported
Not reported
Not reported
Not reported
Constipation
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
24.5
Not reported
Not reported
Not reported
Not reported
Edema-limb
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
20.4
Not reported
Not reported
Not reported
Not reported
Hyponatremia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
20.4
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
63.3
title
Fatigue
categories
measurements
group Id
OG000
value
46.9
title
Nausea
categories
measurements
group Id
OG000
value
40.8
title
Hemoglobin
categories
measurements
group Id
OG000
value
40.8
title
Neuropathy-sensory
categories
measurements
group Id
OG000
value
34.7
title
Alanine transaminase
categories
measurements
group Id
OG000
value
34.7
title
Hyperglycemia
categories
measurements
group Id
OG000
value
34.7
title
Hypoalbuminemia
categories
measurements
group Id
OG000
value
34.7
title
Leukocytes
categories
measurements
group Id
OG000
value
32.7
title
Fever
categories
measurements
group Id
OG000
value
30.6
title
Hypocalcemia
categories
measurements
group Id
OG000
value
30.6
title
Lymphopenia
categories
measurements
group Id
OG000
value
28.6
title
Aspartate transaminase
denoms
counts
group Id
OG000
value
49
units
Participants
description
An adverse event (AE) was any medical occurrence in a participant who was administered denileukin diftitox and cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), and did not necessarily have a causal relationship with this treatment. An AE included any side effect, injury, toxicity, sensitivity reaction, or any undesirable clinical or laboratory event that was not normally observed in the participant. Safety was assessed for all participants who received at least one dose of study medication and was monitored throughout the study. Safety evaluations were based on the incidence, intensity, and type of AE, and clinically significant changes in the participant's medical history, physical examination findings, vital signs, and clinical laboratory results. Participants also notified the study staff of any problems that occurred between visits by telephone, and if necessary, were evaluated by the investigator or study staff at an unscheduled interim visit.
groups
description
Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.
id
OG000
title
Denileukin Diftitox in Combination With CHOP
param Type
NUMBER
population Description
The Safety Population was used and defined as all treated participants. Participants who did not receive at least one dose of study medication were excluded from this population. For this study, the safety population is the same as the Intent to Treat (ITT) population.
reporting Status
POSTED
time Frame
From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months
title
Summary of All Adverse Events by Frequency in Greater Than 20% of Treated Participants
Triangle