NCT03430843 · ADVERSE EVENTS

Adverse events

A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma · Source last updated 2024-10-26

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: All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
Other-event reporting threshold: 3%

All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Tislelizumab Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.	109 / 255	232 / 255	233 / 256
Investigator Chosen Chemotherapy (ICC) Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days	106 / 240	231 / 240	233 / 256

Group identifiers: EG000: Tislelizumab · EG001: Investigator Chosen Chemotherapy (ICC)

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 (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
1
num At Risk
240
num Events
1
term
Agranulocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
255
num Events
1
group Id
EG001
num Affected
3
num At Risk
240
num Events
9
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
8
num At Risk
240
num Events
9
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
1
num At Risk
240
num Events
1
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
4
num At Risk
240
num Events
7
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
1
num At Risk
240
num Events
1
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
2
num At Risk
240
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
1
num At Risk
240
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
1
num At Risk
240
num Events
1
term
Acute left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
255
num Events
1
group Id
EG001
num Affected
0
num At Risk
240
num Events
0
term
Autoimmune myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
1
num At Risk
240
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
255
num Events
1
group Id
EG001
num Affected
0
num At Risk
240
num Events
0
term
Cardio-respiratory arrest

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
80
num At Risk
255
num Events
139
group Id
EG001
num Affected
109
num At Risk
240
num Events
192
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
9
num At Risk
255
num Events
19
group Id
EG001
num Affected
29
num At Risk
240
num Events
57
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
2
num At Risk
255
num Events
11
group Id
EG001
num Affected
30
num At Risk
240
num Events
56
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
5
num At Risk
255
num Events
7
group Id
EG001
num Affected
10
num At Risk
240
num Events
13
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
8
num At Risk
255
num Events
8
group Id
EG001
num Affected
1
num At Risk
240
num Events
1
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
30
num At Risk
255
num Events
37
group Id
EG001
num Affected
1
num At Risk
240
num Events
1
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
9
num At Risk
255
num Events
10
group Id
EG001
num Affected
8
num At Risk
240
num Events
9
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
17
num At Risk
255
num Events
20
group Id
EG001
num Affected
22
num At Risk
240
num Events
27
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
9
num At Risk
255
num Events
12
group Id
EG001
num Affected
16
num At Risk
240
num Events
18
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
41
num At Risk
255
num Events
46
group Id
EG001
num Affected
45
num At Risk
240
num Events
60
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
32
num At Risk
255
num Events
47
group Id
EG001
num Affected
75
num At Risk
240
num Events
134
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
22
num At Risk
255
num Events
23
group Id
EG001
num Affected
17
num At Risk
240
num Events
22
term
Dysphagia

Complete source fields

description

event Groups

deaths Num Affected
233
deaths Num At Risk
256
description
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
id
EG000
other Num Affected
232
other Num At Risk
255
serious Num Affected
109
serious Num At Risk
255
title
Tislelizumab
deaths Num Affected
233
deaths Num At Risk
256
description
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
id
EG001
other Num Affected
231
other Num At Risk
240
serious Num Affected
106
serious Num At Risk
240
title
Investigator Chosen Chemotherapy (ICC)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
80
num At Risk
255
num Events
139
group Id
EG001
num Affected
109
num At Risk
240
num Events
192
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
9
num At Risk
255
num Events
19
group Id
EG001
num Affected
29
num At Risk
240
num Events
57
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
2
num At Risk
255
num Events
11
group Id
EG001
num Affected
30
num At Risk
240
num Events
56
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
5
num At Risk
255
num Events
7
group Id
EG001
num Affected
10
num At Risk
240
num Events
13
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
8
num At Risk
255
num Events
8
group Id
EG001
num Affected
1
num At Risk
240
num Events
1
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
30
num At Risk
255
num Events
37
group Id
EG001
num Affected
1
num At Risk
240
num Events
1
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
9
num At Risk
255
num Events
10
group Id
EG001
num Affected
8
num At Risk
240
num Events
9
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
17
num At Risk
255
num Events
20
group Id
EG001
num Affected
22
num At Risk
240
num Events
27
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
9
num At Risk
255
num Events
12
group Id
EG001
num Affected
16
num At Risk
240
num Events
18
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
41
num At Risk
255
num Events
46
group Id
EG001
num Affected
45
num At Risk
240
num Events
60
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
32
num At Risk
255
num Events
47
group Id
EG001
num Affected
75
num At Risk
240
num Events
134
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
22
num At Risk
255
num Events
23
group Id
EG001
num Affected
17
num At Risk
240
num Events
22
term
Dysphagia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
1
num At Risk
240
num Events
1
term
Agranulocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
255
num Events
1
group Id
EG001
num Affected
3
num At Risk
240
num Events
9
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
8
num At Risk
240
num Events
9
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
1
num At Risk
240
num Events
1
term
Iron deficiency anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
4
num At Risk
240
num Events
7
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
1
num At Risk
240
num Events
1
term
Myelosuppression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
2
num At Risk
240
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
1
num At Risk
240
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
1
num At Risk
240
num Events
1
term
Acute left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
255
num Events
1
group Id
EG001
num Affected
0
num At Risk
240
num Events
0
term
Autoimmune myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
0
num At Risk
255
num Events
0
group Id
EG001
num Affected
1
num At Risk
240
num Events
1
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (25.0)
stats
group Id
EG000
num Affected
1
num At Risk
255
num Events
1
group Id
EG001
num Affected
0
num At Risk
240
num Events
0
term
Cardio-respiratory arrest

time Frame

All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months

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