NCT02500043 · ADVERSE EVENTS

Adverse events

Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer · Source last updated 2024-09-03

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 first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Other-event reporting threshold: 0%

Analysis was performed on the AT population.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
TAS-102+BSC Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.	143 / 335	319 / 335	252 / 335
Placebo+BSC Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.	70 / 168	151 / 168	141 / 168

Group identifiers: EG000: TAS-102+BSC · EG001: Placebo+BSC

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 20.1
stats
group Id
EG000
num Affected
13
num At Risk
335
num Events
13
group Id
EG001
num Affected
4
num At Risk
168
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
2
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
4
num At Risk
335
num Events
4
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
4
num At Risk
335
num Events
5
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
7
num At Risk
335
num Events
7
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
1
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
335
num Events
2
group Id
EG001
num Affected
1
num At Risk
168
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
1
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
1
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Cardio-Respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
335
num Events
2
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
1
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
1
group Id
EG001
num Affected
1
num At Risk
168
num Events
1
term
Abdominal distension

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 20.1
stats
group Id
EG000
num Affected
142
num At Risk
335
num Events
249
group Id
EG001
num Affected
30
num At Risk
168
num Events
52
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
1
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
1
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
335
num Events
2
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
57
num At Risk
335
num Events
116
group Id
EG001
num Affected
3
num At Risk
168
num Events
14
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
1
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
335
num Events
0
group Id
EG001
num Affected
1
num At Risk
168
num Events
1
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
20
num At Risk
335
num Events
42
group Id
EG001
num Affected
8
num At Risk
168
num Events
21
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
128
num At Risk
335
num Events
312
group Id
EG001
num Affected
6
num At Risk
168
num Events
9
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
335
num Events
0
group Id
EG001
num Affected
1
num At Risk
168
num Events
1
term
Neutrophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
3
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
32
num At Risk
335
num Events
45
group Id
EG001
num Affected
2
num At Risk
168
num Events
2
term
Thrombocytopenia

Complete source fields

description

Analysis was performed on the AT population.

event Groups

deaths Num Affected
252
deaths Num At Risk
335
description
Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
id
EG000
other Num Affected
319
other Num At Risk
335
serious Num Affected
143
serious Num At Risk
335
title
TAS-102+BSC
deaths Num Affected
141
deaths Num At Risk
168
description
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
id
EG001
other Num Affected
151
other Num At Risk
168
serious Num Affected
70
serious Num At Risk
168
title
Placebo+BSC

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
142
num At Risk
335
num Events
249
group Id
EG001
num Affected
30
num At Risk
168
num Events
52
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
1
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
1
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
335
num Events
2
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
57
num At Risk
335
num Events
116
group Id
EG001
num Affected
3
num At Risk
168
num Events
14
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
1
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
335
num Events
0
group Id
EG001
num Affected
1
num At Risk
168
num Events
1
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
20
num At Risk
335
num Events
42
group Id
EG001
num Affected
8
num At Risk
168
num Events
21
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
128
num At Risk
335
num Events
312
group Id
EG001
num Affected
6
num At Risk
168
num Events
9
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
335
num Events
0
group Id
EG001
num Affected
1
num At Risk
168
num Events
1
term
Neutrophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
3
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
32
num At Risk
335
num Events
45
group Id
EG001
num Affected
2
num At Risk
168
num Events
2
term
Thrombocytopenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
13
num At Risk
335
num Events
13
group Id
EG001
num Affected
4
num At Risk
168
num Events
5
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
2
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
4
num At Risk
335
num Events
4
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
4
num At Risk
335
num Events
5
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
7
num At Risk
335
num Events
7
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
1
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
335
num Events
2
group Id
EG001
num Affected
1
num At Risk
168
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
1
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
1
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Cardio-Respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
335
num Events
2
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
1
group Id
EG001
num Affected
0
num At Risk
168
num Events
0
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
335
num Events
1
group Id
EG001
num Affected
1
num At Risk
168
num Events
1
term
Abdominal distension

time Frame

From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice