Summary of Study Drug-Related (Possible, Probable, or Definite) Serious Adverse Events
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
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
A serious adverse event (SAE) was any AE that occurred at any dose and resulted in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that did not result in death, were life-threatening, or required hospitalization were considered a SAE when based upon appropriate medical judgment, jeopardized the participant and required medical or surgical intervention to prevent one of the outcomes listed above. Possibly Related (Poss Rel) applied to AEs judged to be perhaps related to study medication, Probably Related (Prob Rel) applied to AEs judged to have a high degree of certainty as related to study medication, and Definitely Related (Def Rel) related applied to AEs that were judged to be without a doubt related to study medication.
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
Febrile neutropenia (grade 3) Prob Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Febrile neutropenia (grade 3) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
4
Not reported
Not reported
Not reported
Not reported
Fever (grade 3) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Fever (grade 2) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Thrombosis/embolism (grade 3) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Neutrophils (grade 3) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Neutrophils (grade 4) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
3
Not reported
Not reported
Not reported
Not reported
Left vent. diastolic dysfunct. (grade 1) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Allergic reaction (grade 4) Def Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Platelets (grade 4) Prob Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Platelets (grade 4) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2
Not reported
Not reported
Not reported
Not reported
Dyspnea (grade 3) Prob Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Pneumonitis (grade 3) Prob Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Lung Inf, 0-2 ANC: lung (grade 3) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Leukocytes (grade 4) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2
Not reported
Not reported
Not reported
Not reported
Leukocytes (grade 4) Prob Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Lymphopenia (grade 4) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
2
Not reported
Not reported
Not reported
Not reported
Inf, 3-4 ANC: cath-related (grade 3) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Allergy-other (grade 1) Def Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Infection-other (grade 3) Poss Rrel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Cardiac ischemia (grade 5) Def Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Tumor lysis syndrome (grade 5) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Cardiopulmonary arrest (grade 4) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Supra Arrhyth: Sinus Tachy. (grade 4) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Death, NOS (grade 5) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Edema-limb (grade 1) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Pain-other (grade 3) Poss Rel
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Denileukin Diftitox in Combination With CHOP
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
1
title
Febrile neutropenia (grade 3) Prob Rel
categories
measurements
group Id
OG000
value
4
title
Febrile neutropenia (grade 3) Poss Rel
categories
measurements
group Id
OG000
value
1
title
Fever (grade 3) Poss Rel
categories
measurements
group Id
OG000
value
1
title
Fever (grade 2) Poss Rel
categories
measurements
group Id
OG000
value
1
title
Thrombosis/embolism (grade 3) Poss Rel
categories
measurements
group Id
OG000
value
1
title
Neutrophils (grade 3) Poss Rel
categories
measurements
group Id
OG000
value
3
title
Neutrophils (grade 4) Poss Rel
categories
measurements
group Id
OG000
value
1
title
Left vent. diastolic dysfunct. (grade 1) Poss Rel
categories
measurements
group Id
OG000
value
1
title
Allergic reaction (grade 4) Def Rel
categories
measurements
group Id
OG000
value
1
title
Platelets (grade 4) Prob Rel
categories
measurements
group Id
OG000
value
2
title
Platelets (grade 4) Poss Rel
categories
measurements
group Id
OG000
value
1
title
Dyspnea (grade 3) Prob Rel
denoms
counts
group Id
OG000
value
49
units
Participants
description
A serious adverse event (SAE) was any AE that occurred at any dose and resulted in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that did not result in death, were life-threatening, or required hospitalization were considered a SAE when based upon appropriate medical judgment, jeopardized the participant and required medical or surgical intervention to prevent one of the outcomes listed above. Possibly Related (Poss Rel) applied to AEs judged to be perhaps related to study medication, Probably Related (Prob Rel) applied to AEs judged to have a high degree of certainty as related to study medication, and Definitely Related (Def Rel) related applied to AEs that were judged to be without a doubt related to study medication.
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 Study Drug-Related (Possible, Probable, or Definite) Serious Adverse Events
Triangle