NCT01607957 · ADVERSE EVENTS

Adverse events

Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies · Source last updated 2024-09-19

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 the time of signing the informed consent form until the period of participant follow up (30 days following the administration of last dose of study medication or until initiation of new anti-tumor therapy, whichever was earlier, up to 85 weeks approximately (duration of study)).
Other-event reporting threshold: 5%

Safety analysis was performed on AT population including all participants who took part of any dose of the study medication.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
TAS-102 Participants received TAS-102 orally with a starting dose of 35 mg/m\^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.	158 / 533	506 / 533	17 / 533
Placebo Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.	89 / 265	227 / 265	30 / 265

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

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 (16.0)
stats
group Id
EG000
num Affected
10
num At Risk
533
num Events
10
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
533
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
14
num At Risk
533
num Events
14
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
533
num Events
2
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
4
num At Risk
533
num Events
4
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
533
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
533
num Events
2
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
533
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
533
num Events
0
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Cardiac tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
533
num Events
1
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Cardio-Respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
533
num Events
0
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
533
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Pericardial effusion

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 (16.0)
stats
group Id
EG000
num Affected
205
num At Risk
533
num Events
265
group Id
EG001
num Affected
22
num At Risk
265
num Events
24
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
27
num At Risk
533
num Events
34
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
152
num At Risk
533
num Events
327
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
35
num At Risk
533
num Events
58
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
74
num At Risk
533
num Events
83
group Id
EG001
num Affected
32
num At Risk
265
num Events
32
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
38
num At Risk
533
num Events
40
group Id
EG001
num Affected
12
num At Risk
265
num Events
15
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
81
num At Risk
533
num Events
87
group Id
EG001
num Affected
40
num At Risk
265
num Events
42
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
167
num At Risk
533
num Events
240
group Id
EG001
num Affected
33
num At Risk
265
num Events
39
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
256
num At Risk
533
num Events
410
group Id
EG001
num Affected
63
num At Risk
265
num Events
73
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
42
num At Risk
533
num Events
54
group Id
EG001
num Affected
16
num At Risk
265
num Events
17
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
142
num At Risk
533
num Events
217
group Id
EG001
num Affected
38
num At Risk
265
num Events
57
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
96
num At Risk
533
num Events
116
group Id
EG001
num Affected
29
num At Risk
265
num Events
29
term
Asthenia

Complete source fields

description

Safety analysis was performed on AT population including all participants who took part of any dose of the study medication.

event Groups

deaths Num Affected
17
deaths Num At Risk
533
description
Participants received TAS-102 orally with a starting dose of 35 mg/m\^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.
id
EG000
other Num Affected
506
other Num At Risk
533
serious Num Affected
158
serious Num At Risk
533
title
TAS-102
deaths Num Affected
30
deaths Num At Risk
265
description
Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.
id
EG001
other Num Affected
227
other Num At Risk
265
serious Num Affected
89
serious Num At Risk
265
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
205
num At Risk
533
num Events
265
group Id
EG001
num Affected
22
num At Risk
265
num Events
24
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
27
num At Risk
533
num Events
34
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
152
num At Risk
533
num Events
327
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
35
num At Risk
533
num Events
58
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
74
num At Risk
533
num Events
83
group Id
EG001
num Affected
32
num At Risk
265
num Events
32
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
38
num At Risk
533
num Events
40
group Id
EG001
num Affected
12
num At Risk
265
num Events
15
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
81
num At Risk
533
num Events
87
group Id
EG001
num Affected
40
num At Risk
265
num Events
42
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
167
num At Risk
533
num Events
240
group Id
EG001
num Affected
33
num At Risk
265
num Events
39
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
256
num At Risk
533
num Events
410
group Id
EG001
num Affected
63
num At Risk
265
num Events
73
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
42
num At Risk
533
num Events
54
group Id
EG001
num Affected
16
num At Risk
265
num Events
17
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
142
num At Risk
533
num Events
217
group Id
EG001
num Affected
38
num At Risk
265
num Events
57
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
96
num At Risk
533
num Events
116
group Id
EG001
num Affected
29
num At Risk
265
num Events
29
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
10
num At Risk
533
num Events
10
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
533
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
14
num At Risk
533
num Events
14
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
533
num Events
2
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
4
num At Risk
533
num Events
4
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
533
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
2
num At Risk
533
num Events
2
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
533
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
533
num Events
0
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Cardiac tamponade
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
533
num Events
1
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Cardio-Respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
0
num At Risk
533
num Events
0
group Id
EG001
num Affected
1
num At Risk
265
num Events
1
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
1
num At Risk
533
num Events
1
group Id
EG001
num Affected
0
num At Risk
265
num Events
0
term
Pericardial effusion

time Frame

From the time of signing the informed consent form until the period of participant follow up (30 days following the administration of last dose of study medication or until initiation of new anti-tumor therapy, whichever was earlier, up to 85 weeks approximately (duration of study)).

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Preserved source evidence · Independent clinical review pending · Not medical advice