NCT01343277 · ADVERSE EVENTS

Adverse events

A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma · Source last updated 2016-08-26

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: approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]
Other-event reporting threshold: 5%

Safety population included all the treated participants.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Trabectedin Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.	155 / 378	375 / 378	Not reported / Not reported
Dacarbazine Dacarbazine at a dose of 1 gram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.	52 / 172	166 / 172	Not reported / Not reported

Group identifiers: EG000: Trabectedin · EG001: Dacarbazine

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
15
num At Risk
378
group Id
EG001
num Affected
4
num At Risk
172
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
12
num At Risk
378
group Id
EG001
num Affected
2
num At Risk
172
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
3
num At Risk
378
group Id
EG001
num Affected
0
num At Risk
172
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
4
num At Risk
378
group Id
EG001
num Affected
3
num At Risk
172
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
1
num At Risk
378
group Id
EG001
num Affected
0
num At Risk
172
term
Microangiopathic Haemolytic Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
9
num At Risk
378
group Id
EG001
num Affected
1
num At Risk
172
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
7
num At Risk
378
group Id
EG001
num Affected
3
num At Risk
172
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
2
num At Risk
378
group Id
EG001
num Affected
1
num At Risk
172
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
1
num At Risk
378
group Id
EG001
num Affected
0
num At Risk
172
term
Atrial Flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
3
num At Risk
378
group Id
EG001
num Affected
0
num At Risk
172
term
Cardiac Arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
1
num At Risk
378
group Id
EG001
num Affected
0
num At Risk
172
term
Cardiac Disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
3
num At Risk
378
group Id
EG001
num Affected
0
num At Risk
172
term
Cardiac 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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
149
num At Risk
378
group Id
EG001
num Affected
48
num At Risk
172
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
43
num At Risk
378
group Id
EG001
num Affected
11
num At Risk
172
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
111
num At Risk
378
group Id
EG001
num Affected
31
num At Risk
172
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
70
num At Risk
378
group Id
EG001
num Affected
33
num At Risk
172
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
30
num At Risk
378
group Id
EG001
num Affected
16
num At Risk
172
term
Abdominal Distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
58
num At Risk
378
group Id
EG001
num Affected
29
num At Risk
172
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
19
num At Risk
378
group Id
EG001
num Affected
8
num At Risk
172
term
Abdominal Pain Upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
140
num At Risk
378
group Id
EG001
num Affected
52
num At Risk
172
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
130
num At Risk
378
group Id
EG001
num Affected
40
num At Risk
172
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
22
num At Risk
378
group Id
EG001
num Affected
13
num At Risk
172
term
Dry Mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
30
num At Risk
378
group Id
EG001
num Affected
12
num At Risk
172
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
12
num At Risk
378
group Id
EG001
num Affected
11
num At Risk
172
term
Gastrooesophageal Reflux Disease

Complete source fields

description

Safety population included all the treated participants.

event Groups

description
Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
id
EG000
other Num Affected
375
other Num At Risk
378
serious Num Affected
155
serious Num At Risk
378
title
Trabectedin
description
Dacarbazine at a dose of 1 gram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
id
EG001
other Num Affected
166
other Num At Risk
172
serious Num Affected
52
serious Num At Risk
172
title
Dacarbazine

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
149
num At Risk
378
group Id
EG001
num Affected
48
num At Risk
172
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
43
num At Risk
378
group Id
EG001
num Affected
11
num At Risk
172
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
111
num At Risk
378
group Id
EG001
num Affected
31
num At Risk
172
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
70
num At Risk
378
group Id
EG001
num Affected
33
num At Risk
172
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
30
num At Risk
378
group Id
EG001
num Affected
16
num At Risk
172
term
Abdominal Distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
58
num At Risk
378
group Id
EG001
num Affected
29
num At Risk
172
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
19
num At Risk
378
group Id
EG001
num Affected
8
num At Risk
172
term
Abdominal Pain Upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
140
num At Risk
378
group Id
EG001
num Affected
52
num At Risk
172
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
130
num At Risk
378
group Id
EG001
num Affected
40
num At Risk
172
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
22
num At Risk
378
group Id
EG001
num Affected
13
num At Risk
172
term
Dry Mouth
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
30
num At Risk
378
group Id
EG001
num Affected
12
num At Risk
172
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
12
num At Risk
378
group Id
EG001
num Affected
11
num At Risk
172
term
Gastrooesophageal Reflux Disease

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
15
num At Risk
378
group Id
EG001
num Affected
4
num At Risk
172
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
12
num At Risk
378
group Id
EG001
num Affected
2
num At Risk
172
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
3
num At Risk
378
group Id
EG001
num Affected
0
num At Risk
172
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
4
num At Risk
378
group Id
EG001
num Affected
3
num At Risk
172
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
1
num At Risk
378
group Id
EG001
num Affected
0
num At Risk
172
term
Microangiopathic Haemolytic Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
9
num At Risk
378
group Id
EG001
num Affected
1
num At Risk
172
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
7
num At Risk
378
group Id
EG001
num Affected
3
num At Risk
172
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
2
num At Risk
378
group Id
EG001
num Affected
1
num At Risk
172
term
Atrial Fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
1
num At Risk
378
group Id
EG001
num Affected
0
num At Risk
172
term
Atrial Flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
3
num At Risk
378
group Id
EG001
num Affected
0
num At Risk
172
term
Cardiac Arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
1
num At Risk
378
group Id
EG001
num Affected
0
num At Risk
172
term
Cardiac Disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 16.0
stats
group Id
EG000
num Affected
3
num At Risk
378
group Id
EG001
num Affected
0
num At Risk
172
term
Cardiac Failure

time Frame

approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]

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

Preserved source evidence · Not medical advice