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.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 3 years
What was measured
Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Toxicities table summarizes the observed incidence by severity and type of toxicity for toxicities that are related to treatment and greater than grade 1. Adverse events assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Groups in this outcome
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
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Treatment (Belinostat)
13
Reported measurements
Grade 2 : Hemoglobin
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
6
Not reported
Not reported
Not reported
Not reported
Grade 2 : Lymphopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
1
Not reported
Not reported
Not reported
Not reported
Grade 2 : Albumin
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
1
Not reported
Not reported
Not reported
Not reported
Grade 2 : Anorexia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
2
Not reported
Not reported
Not reported
Not reported
Grade 2 : AST
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 2 : Constipation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
2
Not reported
Not reported
Not reported
Not reported
Grade 2 : Creatinine
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
1
Not reported
Not reported
Not reported
Not reported
Grade 2 : Sweating
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
1
Not reported
Not reported
Not reported
Not reported
Grade 2 : Dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
3
Not reported
Not reported
Not reported
Not reported
Grade 2 : Fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 2 : Glucose (hyperglycemia)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
6
Not reported
Not reported
Not reported
Not reported
Grade 2 : Hypoxia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 2 : Hypotension
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
1
Not reported
Not reported
Not reported
Not reported
Grade 2 : Infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
2
Not reported
Not reported
Not reported
Not reported
Grade 2 : Nausea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
2
Not reported
Not reported
Not reported
Not reported
Grade 2 : Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
1
Not reported
Not reported
Not reported
Not reported
Grade 2 : Sodium (Hyponatremia)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 2 : Supraventricular arrhythmia NOS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
2
Not reported
Not reported
Not reported
Not reported
Grade 3 : Hemoglobin
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 3 : Lymphopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 3 : Albumin
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 3 : Anorexia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 3 : AST
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
1
Not reported
Not reported
Not reported
Not reported
Grade 3 : Constipation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 3 : Creatinine
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 3 : Sweating
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 3 : Dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
1
Not reported
Not reported
Not reported
Not reported
Grade 3 : Fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
2
Not reported
Not reported
Not reported
Not reported
Grade 3 : Glucose (hyperglycemia)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 3 : Hypoxia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 3 : Hypotension
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 3 : Infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 3 : Nausea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 3 : Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 3 : Sodium (Hyponatremia)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
3
Not reported
Not reported
Not reported
Not reported
Grade 3 : Supraventricular arrhythmia NOS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
1
Not reported
Not reported
Not reported
Not reported
Grade 4 : Hemoglobin
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 4 : Lymphopenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 4 : Albumin
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 4 : Anorexia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 4 : AST
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 4 : Constipation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 4 : Creatinine
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 4 : Sweating
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 4 : Dyspnea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
1
Not reported
Not reported
Not reported
Not reported
Grade 4 : Fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 4 : Glucose (hyperglycemia)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 4 : Hypoxia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
1
Not reported
Not reported
Not reported
Not reported
Grade 4 : Hypotension
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 4 : Infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 4 : Nausea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 4 : Pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 4 : Sodium (Hyponatremia)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Grade 4 : Supraventricular arrhythmia NOS
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Treatment (Belinostat)
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
calculate Pct
false
classes
categories
measurements
group Id
OG000
value
6
title
Grade 2 : Hemoglobin
categories
measurements
group Id
OG000
value
1
title
Grade 2 : Lymphopenia
categories
measurements
group Id
OG000
value
1
title
Grade 2 : Albumin
categories
measurements
group Id
OG000
value
2
title
Grade 2 : Anorexia
categories
measurements
group Id
OG000
value
0
title
Grade 2 : AST
categories
measurements
group Id
OG000
value
2
title
Grade 2 : Constipation
categories
measurements
group Id
OG000
value
1
title
Grade 2 : Creatinine
categories
measurements
group Id
OG000
value
1
title
Grade 2 : Sweating
categories
measurements
group Id
OG000
value
3
title
Grade 2 : Dyspnea
categories
measurements
group Id
OG000
value
0
title
Grade 2 : Fatigue
categories
measurements
group Id
OG000
value
6
title
Grade 2 : Glucose (hyperglycemia)
categories
measurements
group Id
OG000
value
0
title
Grade 2 : Hypoxia
denoms
counts
group Id
OG000
value
13
units
Participants
description
Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Toxicities table summarizes the observed incidence by severity and type of toxicity for toxicities that are related to treatment and greater than grade 1. Adverse events assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
groups
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
Triangle