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NCT02158975 · OUTCOME

Number Patients That Experience Adverse Events, Grades 3-5

Open-label, Phase II Study of MLN9708 in Patients With Relapsed/Refractory Cutaneous and Peripheral T-cell Lymphomas · Source last updated 2017-11-13

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
30 days after the last dose of study drug

What was measured

To assess the safety and tolerability of MLN9708, the number of patients experiencing Adverse Events (AEs) greater than or equal to grade 3 will be recorded.

Groups in this outcome

MLN9708

MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days. MLN9708

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

Analysis denominator · Participants

GroupSource count
MLN970812

Reported measurements

Anemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN97081Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN97081Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN97081Not reportedNot reportedNot reportedNot reported
Mucocitis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN97081Not reportedNot reportedNot reportedNot reported
Acute Kidney Injury
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN97081Not reportedNot reportedNot reportedNot reported
Atrial Fibrilation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN97081Not reportedNot reportedNot reportedNot reported
Dyspnea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN97081Not reportedNot reportedNot reportedNot reported
Hypercalcemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN97081Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN97081Not reportedNot reportedNot reportedNot reported
Hypotension
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN97081Not reportedNot reportedNot reportedNot reported
Lymph Node Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN97081Not reportedNot reportedNot reportedNot reported
Rash
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN97081Not reportedNot reportedNot reportedNot reported
Respiratory Failure
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN97081Not reportedNot reportedNot reportedNot reported
Supraventricular Tachycardia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN97081Not reportedNot reportedNot reportedNot reported
Thromboembolic Event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN97081Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Anemia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Thrombocytopenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Diarrhea
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Mucocitis
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Acute Kidney Injury
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Atrial Fibrilation
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Dyspnea
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hypercalcemia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hyponatremia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hypotension
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Lymph Node Pain
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Rash
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
To assess the safety and tolerability of MLN9708, the number of patients experiencing Adverse Events (AEs) greater than or equal to grade 3 will be recorded.
groups
  1. description
    MLN9708 4mg by mouth weekly (days 1, 8, 15) every 28 days. MLN9708
    id
    OG000
    title
    MLN9708
param Type
NUMBER
reporting Status
POSTED
time Frame
30 days after the last dose of study drug
title
Number Patients That Experience Adverse Events, Grades 3-5
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice