Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs
Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma · Source last updated 2018-07-31
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
What was measured
Clinical laboratory tests included chemistry, hematology and urinalysis test. Clinically significant treatment-emergent laboratory abnormalities were reported by the investigator as TEAEs.
Analysis population: Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received.
Groups in this outcome
Alisertib
Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).
Pralatrexate, or Romidepsin, or Gemcitabine
Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
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
Alisertib
137
Pralatrexate, or Romidepsin, or Gemcitabine
127
Reported measurements
Neutrophil Count Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
18
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
14
Not reported
Not reported
Not reported
Not reported
White Blood Cell Count Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
17
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
10
Not reported
Not reported
Not reported
Not reported
Lymphocyte Count Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
6
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
5
Not reported
Not reported
Not reported
Not reported
Monocyte Count Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
2
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
1
Not reported
Not reported
Not reported
Not reported
Lymphocyte Count Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
1
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
0
Not reported
Not reported
Not reported
Not reported
Monocyte Count Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
1
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
0
Not reported
Not reported
Not reported
Not reported
White Blood Cell Count Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
1
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
0
Not reported
Not reported
Not reported
Not reported
Platelet Count Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
15
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
22
Not reported
Not reported
Not reported
Not reported
Alanine Aminotransferase Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
8
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
11
Not reported
Not reported
Not reported
Not reported
Aspartate Aminotransferase Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
5
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
11
Not reported
Not reported
Not reported
Not reported
Gamma-glutamyltransferase Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
6
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
3
Not reported
Not reported
Not reported
Not reported
Blood Bilirubin Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
2
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
1
Not reported
Not reported
Not reported
Not reported
Hepatic Enzyme Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
2
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
0
Not reported
Not reported
Not reported
Not reported
Liver Function Test Abnormal
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
0
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
1
Not reported
Not reported
Not reported
Not reported
Transaminases Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
0
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
1
Not reported
Not reported
Not reported
Not reported
Blood Alkaline Phosphatase Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
9
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
7
Not reported
Not reported
Not reported
Not reported
Blood Lactate Dehydrogenase Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
5
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
1
Not reported
Not reported
Not reported
Not reported
Blood Creatinine Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
3
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
7
Not reported
Not reported
Not reported
Not reported
Blood Creatinine Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
0
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
1
Not reported
Not reported
Not reported
Not reported
Blood Urea Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
1
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
0
Not reported
Not reported
Not reported
Not reported
Blood Potassium Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
1
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
4
Not reported
Not reported
Not reported
Not reported
Blood Magnesium Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
1
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
2
Not reported
Not reported
Not reported
Not reported
Blood Bicarbonate Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
0
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
1
Not reported
Not reported
Not reported
Not reported
Blood Calcium Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
0
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
1
Not reported
Not reported
Not reported
Not reported
Blood Calcium Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
1
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
0
Not reported
Not reported
Not reported
Not reported
Blood Phosphorus Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
0
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
1
Not reported
Not reported
Not reported
Not reported
Calcium Ionised Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
1
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
0
Not reported
Not reported
Not reported
Not reported
Haemoglobin Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
1
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
3
Not reported
Not reported
Not reported
Not reported
Haematocrit Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
1
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
2
Not reported
Not reported
Not reported
Not reported
Haematocrit Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
1
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
0
Not reported
Not reported
Not reported
Not reported
Coagulation Factor XIII Level Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
1
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
0
Not reported
Not reported
Not reported
Not reported
International Normalised Ratio Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
1
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
0
Not reported
Not reported
Not reported
Not reported
Blood Albumin Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
0
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
2
Not reported
Not reported
Not reported
Not reported
Myocardial Necrosis Marker Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
1
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
0
Not reported
Not reported
Not reported
Not reported
Troponin Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
0
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
1
Not reported
Not reported
Not reported
Not reported
Blood Glucose Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
0
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
1
Not reported
Not reported
Not reported
Not reported
Immunoglobulins Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
1
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
0
Not reported
Not reported
Not reported
Not reported
Blood Uric Acid Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
1
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
0
Not reported
Not reported
Not reported
Not reported
Enterovirus Test Positive
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Alisertib
0
Not reported
Not reported
Not reported
Not reported
Pralatrexate, or Romidepsin, or Gemcitabine
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
18
group Id
OG001
value
14
title
Neutrophil Count Decreased
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
10
title
White Blood Cell Count Decreased
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
5
title
Lymphocyte Count Decreased
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
title
Monocyte Count Decreased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Lymphocyte Count Increased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Monocyte Count Increased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
White Blood Cell Count Increased
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
22
title
Platelet Count Decreased
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
11
title
Alanine Aminotransferase Increased
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
11
title
Aspartate Aminotransferase Increased
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
3
title
Gamma-glutamyltransferase Increased
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
title
Blood Bilirubin Increased
denoms
counts
group Id
OG000
value
137
group Id
OG001
value
127
units
Participants
description
Clinical laboratory tests included chemistry, hematology and urinalysis test. Clinically significant treatment-emergent laboratory abnormalities were reported by the investigator as TEAEs.
groups
description
Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).
id
OG000
title
Alisertib
description
Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
id
OG001
title
Pralatrexate, or Romidepsin, or Gemcitabine
param Type
NUMBER
population Description
Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received.
reporting Status
POSTED
time Frame
First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
title
Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs