NCT01401530 · ADVERSE EVENTS

Adverse events

E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma · Source last updated 2018-11-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months
Other-event reporting threshold: 0%

Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1: 6 ug/kg/Day Denileukin Diftitox Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	1 / 3	3 / 3	1 / 3
Cohort 2: 9 ug/kg/Day Denileukin Diftitox Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	3 / 7	7 / 7	0 / 7
Cohort 3: 12 ug/kg/Day Denileukin Diftitox Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	1 / 3	3 / 3	1 / 3

Group identifiers: EG000: Cohort 1: 6 ug/kg/Day Denileukin Diftitox · EG001: Cohort 2: 9 ug/kg/Day Denileukin Diftitox · EG002: Cohort 3: 12 ug/kg/Day Denileukin Diftitox

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Decreased appetite
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Delirium
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Aspartate Aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Infected skin ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
term
Respiratory Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
term
Hepatic Failure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
4
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
3
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
4
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
3
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
4
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Face Oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
term
Generalised oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
term
Infusion site extravasation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
term
Injection site swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Peripheral swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
5
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
3
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
5
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
3
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
4
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
3
term
Lymphocyte count decreased

Complete source fields

description

event Groups

deaths Num Affected
1
deaths Num At Risk
3
description
Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Cohort 1: 6 ug/kg/Day Denileukin Diftitox
deaths Num Affected
0
deaths Num At Risk
7
description
Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
id
EG001
other Num Affected
7
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
Cohort 2: 9 ug/kg/Day Denileukin Diftitox
deaths Num Affected
1
deaths Num At Risk
3
description
Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Cohort 3: 12 ug/kg/Day Denileukin Diftitox

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
4
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
3
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
4
num At Risk
7
group Id
EG002
num Affected
2
num At Risk
3
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
4
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
2
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Face Oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
term
Generalised oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
term
Infusion site extravasation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
term
Injection site swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Peripheral swelling
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
5
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
3
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
2
num At Risk
3
group Id
EG001
num Affected
5
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
3
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
3
num At Risk
3
group Id
EG001
num Affected
4
num At Risk
7
group Id
EG002
num Affected
3
num At Risk
3
term
Lymphocyte count decreased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Decreased appetite
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Delirium
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Aspartate Aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
1
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
1
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
0
num At Risk
3
term
Infected skin ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
term
Respiratory Failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
0
num At Risk
3
group Id
EG001
num Affected
0
num At Risk
7
group Id
EG002
num Affected
1
num At Risk
3
term
Hepatic Failure

time Frame

From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months

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Preserved source evidence · Not medical advice