NCT00365053 · ADVERSE EVENTS

Adverse events

PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery · Source last updated 2018-06-07

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 1 year, 1 month.
Other-event reporting threshold: 0%

"Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Belinostat) Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies	3 / 13	13 / 13	1 / 13

Group identifiers: EG000: Treatment (Belinostat)

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
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Supraventricular tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Death
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
term
Dyspnea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Hypoxia

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
meddra9.0
stats
group Id
EG000
num Affected
8
num At Risk
13
num Events
11
term
Hemoglobin decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Cardiac valve disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Myocardial ischemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Premature ventricular contractions
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Sinus arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Supraventricular tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
3
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
8
num At Risk
13
num Events
13
term
Constipation

Complete source fields

description

"Other" adverse events table includes all grades and attributions to treatment not included in the "Serious" adverse events table.

event Groups

deaths Num Affected
1
deaths Num At Risk
13
description
Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. belinostat: Given IV laboratory biomarker analysis: Correlative studies
id
EG000
other Num Affected
13
other Num At Risk
13
serious Num Affected
3
serious Num At Risk
13
title
Treatment (Belinostat)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
8
num At Risk
13
num Events
11
term
Hemoglobin decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Atrial flutter
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Cardiac valve disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Myocardial ischemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Palpitations
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Premature ventricular contractions
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Sinus arrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Supraventricular tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
3
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
8
num At Risk
13
num Events
13
term
Constipation

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Supraventricular tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Death
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
meddra10.0
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
term
Dyspnea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Hypoxia

time Frame

Adverse events were collected over a period of 1 year, 1 month.

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Preserved source evidence · Not medical advice