NCT00002663 · ADVERSE EVENTS

Adverse events

Biological Therapy in Treating Patients at High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies · Source last updated 2023-02-13

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 Day 1 through 251.1 months after Day 1 dose
Other-event reporting threshold: 0%

Combined AE data for all enrolled participants are reported because few arms had \<=3 participants which poses a risk of participant identification with rare indications in this study. Treatment-emergent SAEs includes events collected retrospectively and prospectively per protocol. Non-serious AEs were not collected, hence reported as '0'. In participant flow, 'Deaths' are reported as a reason for study discontinuation, whereas in 'All-Cause Mortality' deaths due to any cause are reported.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Overall Total All eligible participants with EBV+ received IV infusion of tabelecleucel or donor-derived EBV-CTL on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.	40 / 58	0 / 0	32 / 58

Group identifiers: EG000: Overall Total

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
3
num At Risk
58
num Events
4
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
2
term
Haemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
2
num At Risk
58
num Events
2
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
1
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
1
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
1
term
Ventricular arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
1
term
Hypopituitarism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
3
num At Risk
58
num Events
3
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
1
term
Anal ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
1
term
Colitis

Other reported adverse events

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

Complete source fields

description

event Groups

deaths Num Affected
32
deaths Num At Risk
58
description
All eligible participants with EBV+ received IV infusion of tabelecleucel or donor-derived EBV-CTL on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
0
other Num At Risk
0
serious Num Affected
40
serious Num At Risk
58
title
Overall Total

frequency Threshold

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
3
num At Risk
58
num Events
4
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
2
term
Haemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
2
num At Risk
58
num Events
2
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
1
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
1
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
1
term
Ventricular arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
1
term
Hypopituitarism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
3
num At Risk
58
num Events
3
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
1
term
Anal ulcer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
num Events
1
term
Colitis

time Frame

From Day 1 through 251.1 months after Day 1 dose

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Preserved source evidence · Not medical advice