Summary of Treatment-Related Adverse Events Greater Than or Equal to Grade 3 by System Organ Class
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
Treatment-related AEs were medical occurrences determined to be possibly, probably, or definitely related to study treatment. Severity grading of the AE was according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) severity scale (grades 1 - 5) with grade 3 representing a severe AE. 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: Safety 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
Allergy/Immunology: Allergic reaction
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Blood/Bone Marrow: Hemoglobin
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
8.2
Not reported
Not reported
Not reported
Not reported
Blood/Bone Marrow: Leukocytes
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
16.3
Not reported
Not reported
Not reported
Not reported
Blood/Bone Marrow: Lymphopenia
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
Blood/Bone Marrow: Neutrophils
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
16.3
Not reported
Not reported
Not reported
Not reported
Blood/Bone Marrow: Platelets
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
12.2
Not reported
Not reported
Not reported
Not reported
Cardiac Arrhythmia: Supra Arrhyth:Sinus Tachy
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Cardiac General: Cardiac ischemia/infarction
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Cardiac General: Cardiopulmonary arrest
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Coagulation: Coagulation-other
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Constitutional symptoms: Fatigue
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Constitutional symptoms: Fever
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Death: Death, NOS
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Infection: Febrile neutropenia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
10.2
Not reported
Not reported
Not reported
Not reported
Infection: Inf, 3-4 ANC: cath-related
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Infection: Infection-other
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Infection: Lung Inf, 0-2 ANC: lung
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Metabolic/Laboratory: Alanine transaminase (ALT)
Values in Percentage of participants · Interval/dispersion: Not reported
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
4.1
Not reported
Not reported
Not reported
Not reported
Metabolic/Laboratory: CPK
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Metabolic/Laboratory: Cholesterol
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Metabolic/Laboratory: GGT
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Metabolic/Laboratory: Hypoalbuminemia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
4.1
Not reported
Not reported
Not reported
Not reported
Metabolic/Laboratory: Hypokalemia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Pain: Pain-other
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Pulmonary/Upper Respiratory: Dyspnea
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
4.1
Not reported
Not reported
Not reported
Not reported
Pulmonary/Upper Respiratory: Hypoxia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Pulmonary/Upper Respiratory: Pneumonitis
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Syndromes: Tumor Lysis syndrome
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2.0
Not reported
Not reported
Not reported
Not reported
Vascular: Thrombosis/embolism
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
4.1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
2.0
title
Allergy/Immunology: Allergic reaction
categories
measurements
group Id
OG000
value
8.2
title
Blood/Bone Marrow: Hemoglobin
categories
measurements
group Id
OG000
value
16.3
title
Blood/Bone Marrow: Leukocytes
categories
measurements
group Id
OG000
value
24.5
title
Blood/Bone Marrow: Lymphopenia
categories
measurements
group Id
OG000
value
16.3
title
Blood/Bone Marrow: Neutrophils
categories
measurements
group Id
OG000
value
12.2
title
Blood/Bone Marrow: Platelets
categories
measurements
group Id
OG000
value
2.0
title
Cardiac Arrhythmia: Supra Arrhyth:Sinus Tachy
categories
measurements
group Id
OG000
value
2.0
title
Cardiac General: Cardiac ischemia/infarction
categories
measurements
group Id
OG000
value
2.0
title
Cardiac General: Cardiopulmonary arrest
categories
measurements
group Id
OG000
value
2.0
title
Coagulation: Coagulation-other
categories
measurements
group Id
OG000
value
2.0
title
Constitutional symptoms: Fatigue
categories
measurements
group Id
OG000
value
2.0
title
Constitutional symptoms: Fever
denoms
counts
group Id
OG000
value
49
units
Participants
description
Treatment-related AEs were medical occurrences determined to be possibly, probably, or definitely related to study treatment. Severity grading of the AE was according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) severity scale (grades 1 - 5) with grade 3 representing a severe AE. 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
Safety 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 Treatment-Related Adverse Events Greater Than or Equal to Grade 3 by System Organ Class
Triangle