Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00718419 · OUTCOME

Number of Participants With Adverse Events (Safety and Adverse Events)

A Study for Patients That Have Been Previously Been Treated in Waldenstrom's Macroglobulinemia or Multiple Myeloma · Source last updated 2020-09-03

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
Treatment start to 30 days after discontinuation of study treatment up to 23.40 months

What was measured

Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 23.40 months.

Analysis population: All participants who received at least one dose of the study drug.

Groups in this outcome

Multiple Myeloma (MM)

Participants diagnosed with MM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.

Waldenstrom's Macroglobulinemia (WM)

Participants diagnosed with WM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.

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

Analysis denominator · Participants

GroupSource count
Multiple Myeloma (MM)14
Waldenstrom's Macroglobulinemia (WM)42

Reported measurements

Serious Adverse Events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM)4Not reportedNot reportedNot reportedNot reported
Waldenstrom's Macroglobulinemia (WM)9Not reportedNot reportedNot reportedNot reported
Other Nonserious Adverse Events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM)12Not reportedNot reportedNot reportedNot reported
Waldenstrom's Macroglobulinemia (WM)42Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        9
    title
    Serious Adverse Events
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        42
    title
    Other Nonserious Adverse Events
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      42
    units
    Participants
description
Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 23.40 months.
groups
  1. description
    Participants diagnosed with MM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
    id
    OG000
    title
    Multiple Myeloma (MM)
  2. description
    Participants diagnosed with WM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
    id
    OG001
    title
    Waldenstrom's Macroglobulinemia (WM)
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants who received at least one dose of the study drug.
reporting Status
POSTED
time Frame
Treatment start to 30 days after discontinuation of study treatment up to 23.40 months
title
Number of Participants With Adverse Events (Safety and Adverse Events)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice