NCT02860286 · ADVERSE EVENTS

Adverse events

Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma · Source last updated 2021-04-09

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: Adverse Events were collected over a period of 2 years.
Other-event reporting threshold: 5%

No other adverse events are listed in the CSR.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1 (Pharmacokinetics) Assessed the pharmacokinetic (PK) and safety profile of single (Cycle 1 day 1) and repeated doses (Cycle 1 day 2 onwards) of 800 mg tazemetostat administered as 400 mg tablets in subjects with relapsed or refractory malignant mesothelioma regardless of BRCA1 associated protein 1 (BAP1) status.	2 / 13	13 / 13	1 / 13
Part 2 (Efficacy) To assess disease control rate (DCR) at 12 weeks (consisting of complete response \[CR\], partial response \[PR\], or stable disease \[SD\]) according to modified RECIST (Nowak, 2005) for thoracic disease or RECIST 1.1 elsewhere in subjects with relapsed or refractory BAP1-deficient malignant mesothelioma treated with tazemetostat	4 / 61	59 / 61	7 / 61

Group identifiers: EG000: Part 1 (Pharmacokinetics) · EG001: Part 2 (Efficacy)

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
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
2
num At Risk
61
num Events
2
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
2
num At Risk
61
num Events
2
term
Pericardial Effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Air embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Deep vein thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Incarcerated umbilical hernia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Intestinal perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Pneumoperitoneum

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
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
6
num At Risk
13
num Events
6
group Id
EG001
num Affected
15
num At Risk
61
num Events
22
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
4
group Id
EG001
num Affected
15
num At Risk
61
num Events
18
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
group Id
EG001
num Affected
5
num At Risk
61
num Events
8
term
Abdominal Distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
7
num At Risk
61
num Events
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
4
num At Risk
61
num Events
5
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
2
num At Risk
61
num Events
2
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Gastrooesophageal Reflux Disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
2
group Id
EG001
num Affected
0
num At Risk
61
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
61
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
61
num Events
0
term
Haemorrhoids
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
4
num At Risk
13
num Events
4
group Id
EG001
num Affected
22
num At Risk
61
num Events
28
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
8
num At Risk
61
num Events
10
term
Asthenia

Complete source fields

description

No other adverse events are listed in the CSR.

event Groups

deaths Num Affected
1
deaths Num At Risk
13
description
Assessed the pharmacokinetic (PK) and safety profile of single (Cycle 1 day 1) and repeated doses (Cycle 1 day 2 onwards) of 800 mg tazemetostat administered as 400 mg tablets in subjects with relapsed or refractory malignant mesothelioma regardless of BRCA1 associated protein 1 (BAP1) status.
id
EG000
other Num Affected
13
other Num At Risk
13
serious Num Affected
2
serious Num At Risk
13
title
Part 1 (Pharmacokinetics)
deaths Num Affected
7
deaths Num At Risk
61
description
To assess disease control rate (DCR) at 12 weeks (consisting of complete response \[CR\], partial response \[PR\], or stable disease \[SD\]) according to modified RECIST (Nowak, 2005) for thoracic disease or RECIST 1.1 elsewhere in subjects with relapsed or refractory BAP1-deficient malignant mesothelioma treated with tazemetostat
id
EG001
other Num Affected
59
other Num At Risk
61
serious Num Affected
4
serious Num At Risk
61
title
Part 2 (Efficacy)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
6
num At Risk
13
num Events
6
group Id
EG001
num Affected
15
num At Risk
61
num Events
22
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
4
group Id
EG001
num Affected
15
num At Risk
61
num Events
18
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
group Id
EG001
num Affected
5
num At Risk
61
num Events
8
term
Abdominal Distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
7
num At Risk
61
num Events
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
4
num At Risk
61
num Events
5
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
2
num At Risk
61
num Events
2
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Gastrooesophageal Reflux Disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
2
group Id
EG001
num Affected
0
num At Risk
61
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
61
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
0
num At Risk
61
num Events
0
term
Haemorrhoids
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
4
num At Risk
13
num Events
4
group Id
EG001
num Affected
22
num At Risk
61
num Events
28
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
8
num At Risk
61
num Events
10
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
2
num At Risk
61
num Events
2
term
Dyspnoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
2
num At Risk
61
num Events
2
term
Pericardial Effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Air embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Deep vein thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Incarcerated umbilical hernia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Intestinal perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (18.1)
stats
group Id
EG000
num Affected
0
num At Risk
13
num Events
0
group Id
EG001
num Affected
1
num At Risk
61
num Events
1
term
Pneumoperitoneum

time Frame

Adverse Events were collected over a period of 2 years.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice