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NCT00461045 · OUTCOME

Number of Patients With 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
COUNT_OF_PARTICIPANTS
Unit
Participants
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

At least one TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^215Not reportedNot reportedNot reportedNot reported
At least one treatment related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^214Not reportedNot reportedNot reportedNot reported
At least one NPI-0052 related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^213Not reportedNot reportedNot reportedNot reported
At least one grade ≥3 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^212Not reportedNot reportedNot reportedNot reported
At least one treatment related grade ≥3 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^28Not reportedNot reportedNot reportedNot reported
At least one NPI-0052 related grade ≥3 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^25Not reportedNot reportedNot reportedNot reported
At least one serious TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^27Not reportedNot reportedNot reportedNot reported
At least one treatment related serious TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MRZ 0.5 mg/m^24Not reportedNot reportedNot reportedNot reported
At least one NPI-0052 related serious TEAE
Values in Participants · 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
        15
    title
    At least one TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    At least one treatment related TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    At least one NPI-0052 related TEAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    At least one grade ≥3 TEAE
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    At least one treatment related grade ≥3 TEAE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    At least one NPI-0052 related grade ≥3 TEAE
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    At least one serious TEAE
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    At least one treatment related serious TEAE
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    At least one NPI-0052 related serious TEAE
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Through study completion, an average of 6.09 weeks.
title
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice