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NCT01466881 · OUTCOME

To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237)

Alisertib in Treating Patients With Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma · Source last updated 2016-03-10

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
Up to 1 year after registration

What was measured

Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Analysis population: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.

Groups in this outcome

MLN8237

Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
MLN823737

Reported measurements

Abdominal pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Alkaline phosphatase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82372Not reportedNot reportedNot reportedNot reported
Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN823712Not reportedNot reportedNot reportedNot reported
Anorexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Back pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Blood bilirubin increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
CD4 lymphocytes decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82372Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Febrile neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82375Not reportedNot reportedNot reportedNot reported
Fever
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Gastrointestinal disorders - Other, specify
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Hypercalcemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Hyperglycemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Hypotension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Infections and infestations - Other, specify
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Leukocytosis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Lung infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Lymph gland infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82378Not reportedNot reportedNot reportedNot reported
Mucositis oral
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82374Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN823712Not reportedNot reportedNot reportedNot reported
Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82372Not reportedNot reportedNot reportedNot reported
Platelet count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82379Not reportedNot reportedNot reportedNot reported
Rash maculo-papular
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82372Not reportedNot reportedNot reportedNot reported
Sepsis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Skin and subcutaneous tissue disorders - Other
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Skin infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Toxic epidermal necrolysis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
Treatment related secondary malignancy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82371Not reportedNot reportedNot reportedNot reported
White blood cell decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82377Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Abdominal pain
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Alkaline phosphatase increased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    Anemia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Anorexia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Back pain
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Blood bilirubin increased
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    CD4 lymphocytes decreased
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Diarrhea
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Fatigue
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Febrile neutropenia
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Fever
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Gastrointestinal disorders - Other, specify
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    units
    Participants
description
Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
groups
  1. description
    Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
    id
    OG000
    title
    MLN8237
param Type
NUMBER
population Description
Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
reporting Status
POSTED
time Frame
Up to 1 year after registration
title
To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice