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NCT00461045 · OUTCOME

Number of Treatment Emergent Adverse Events (TEAEs)

Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma · Source last updated 2017-12-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
TEAEs
Interval / dispersion
Not reported
Time frame
Through study completion, an average of 6.09 weeks.

What was measured

Adverse events were graded using NCI-CTCAE (version 4.3). TEAEs are defined as any adverse event with an onset date between the date of first dose and 30 days after the date of last dose of any study drug. Treatment-related adverse events are adverse events considered related to at least one study drug by the investigator (NPI-002, dexamethasone), including those with unknown relationship.

Groups in this outcome

MRZ 0.5 mg/m^2

Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles

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

Analysis denominator · Participants

GroupSource count
MRZ 0.5 mg/m^215

Reported measurements

Number of TEAEs
Values in TEAEs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^2149Not reportedNot reportedNot reportedNot reported
Number of treatment related TEAEs
Values in TEAEs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^273Not reportedNot reportedNot reportedNot reported
Number of NPI-0052 related TEAEs
Values in TEAEs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^250Not reportedNot reportedNot reportedNot reported
Number of grade ≥3 TEAEs
Values in TEAEs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^241Not reportedNot reportedNot reportedNot reported
Number of treatment related grade ≥3 TEAEs
Values in TEAEs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^216Not reportedNot reportedNot reportedNot reported
Number of NPI-0052 realted grade ≥3 TEAEs
Values in TEAEs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^29Not reportedNot reportedNot reportedNot reported
Number of serious TEAEs
Values in TEAEs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^221Not reportedNot reportedNot reportedNot reported
Number of treatment related serious TEAEs
Values in TEAEs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^25Not reportedNot reportedNot reportedNot reported
Number of NPI-0052 related serious TEAEs
Values in TEAEs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^21Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        149
    title
    Number of TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        73
    title
    Number of treatment related TEAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        50
    title
    Number of NPI-0052 related TEAEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        41
    title
    Number of grade ≥3 TEAEs
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    Number of treatment related grade ≥3 TEAEs
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Number of NPI-0052 realted grade ≥3 TEAEs
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        21
    title
    Number of serious TEAEs
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Number of treatment related serious TEAEs
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Number of NPI-0052 related serious TEAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
Adverse events were graded using NCI-CTCAE (version 4.3). TEAEs are defined as any adverse event with an onset date between the date of first dose and 30 days after the date of last dose of any study drug. Treatment-related adverse events are adverse events considered related to at least one study drug by the investigator (NPI-002, dexamethasone), including those with unknown relationship.
groups
  1. description
    Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
    id
    OG000
    title
    MRZ 0.5 mg/m^2
param Type
NUMBER
reporting Status
POSTED
time Frame
Through study completion, an average of 6.09 weeks.
title
Number of Treatment Emergent Adverse Events (TEAEs)
type
SECONDARY
unit Of Measure
TEAEs

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

Preserved source evidence · Not medical advice