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NCT01482962 · OUTCOME

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

GroupSource count
Alisertib137
Pralatrexate, or Romidepsin, or Gemcitabine127

Reported measurements

Neutrophil Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib18Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine14Not reportedNot reportedNot reportedNot reported
White Blood Cell Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib17Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine10Not reportedNot reportedNot reportedNot reported
Lymphocyte Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib6Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine5Not reportedNot reportedNot reportedNot reported
Monocyte Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib2Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine1Not reportedNot reportedNot reportedNot reported
Lymphocyte Count Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib1Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine0Not reportedNot reportedNot reportedNot reported
Monocyte Count Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib1Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine0Not reportedNot reportedNot reportedNot reported
White Blood Cell Count Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib1Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine0Not reportedNot reportedNot reportedNot reported
Platelet Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib15Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine22Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib8Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine11Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib5Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine11Not reportedNot reportedNot reportedNot reported
Gamma-glutamyltransferase Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib6Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine3Not reportedNot reportedNot reportedNot reported
Blood Bilirubin Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib2Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine1Not reportedNot reportedNot reportedNot reported
Hepatic Enzyme Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib2Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine0Not reportedNot reportedNot reportedNot reported
Liver Function Test Abnormal
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib0Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine1Not reportedNot reportedNot reportedNot reported
Transaminases Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib0Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine1Not reportedNot reportedNot reportedNot reported
Blood Alkaline Phosphatase Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib9Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine7Not reportedNot reportedNot reportedNot reported
Blood Lactate Dehydrogenase Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib5Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine1Not reportedNot reportedNot reportedNot reported
Blood Creatinine Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib3Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine7Not reportedNot reportedNot reportedNot reported
Blood Creatinine Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib0Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine1Not reportedNot reportedNot reportedNot reported
Blood Urea Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib1Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine0Not reportedNot reportedNot reportedNot reported
Blood Potassium Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib1Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine4Not reportedNot reportedNot reportedNot reported
Blood Magnesium Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib1Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine2Not reportedNot reportedNot reportedNot reported
Blood Bicarbonate Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib0Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine1Not reportedNot reportedNot reportedNot reported
Blood Calcium Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib0Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine1Not reportedNot reportedNot reportedNot reported
Blood Calcium Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib1Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine0Not reportedNot reportedNot reportedNot reported
Blood Phosphorus Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib0Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine1Not reportedNot reportedNot reportedNot reported
Calcium Ionised Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib1Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine0Not reportedNot reportedNot reportedNot reported
Haemoglobin Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib1Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine3Not reportedNot reportedNot reportedNot reported
Haematocrit Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib1Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine2Not reportedNot reportedNot reportedNot reported
Haematocrit Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib1Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine0Not reportedNot reportedNot reportedNot reported
Coagulation Factor XIII Level Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib1Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine0Not reportedNot reportedNot reportedNot reported
International Normalised Ratio Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib1Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine0Not reportedNot reportedNot reportedNot reported
Blood Albumin Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib0Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine2Not reportedNot reportedNot reportedNot reported
Myocardial Necrosis Marker Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib1Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine0Not reportedNot reportedNot reportedNot reported
Troponin Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib0Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine1Not reportedNot reportedNot reportedNot reported
Blood Glucose Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib0Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine1Not reportedNot reportedNot reportedNot reported
Immunoglobulins Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib1Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine0Not reportedNot reportedNot reportedNot reported
Blood Uric Acid Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib1Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine0Not reportedNot reportedNot reportedNot reported
Enterovirus Test Positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alisertib0Not reportedNot reportedNot reportedNot reported
Pralatrexate, or Romidepsin, or Gemcitabine1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        14
    title
    Neutrophil Count Decreased
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        10
    title
    White Blood Cell Count Decreased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
    title
    Lymphocyte Count Decreased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    Monocyte Count Decreased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Lymphocyte Count Increased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Monocyte Count Increased
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    White Blood Cell Count Increased
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        22
    title
    Platelet Count Decreased
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        11
    title
    Alanine Aminotransferase Increased
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        11
    title
    Aspartate Aminotransferase Increased
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        3
    title
    Gamma-glutamyltransferase Increased
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    Blood Bilirubin Increased
denoms
  1. counts
    1. group Id
      OG000
      value
      137
    2. 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
  1. 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
  2. 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
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice