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NCT02092909 · OUTCOME

Identify the Number of Patients Experiencing DLTs at Each Dose Level

Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia · Source last updated 2019-09-10

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
28 days

What was measured

To identify an appropriate dose of IMO-8400 for further clinical evaluation via evaluation of DLT at each dose level

Analysis population: Safety Population

Groups in this outcome

IMO-8400 0.6 mg/kg 1x/wk

IMO-8400 0.6 mg/kg once weekly s.c.

IMO-8400 1.2 mg/kg 1x/wk

IMO-8400 1.2 mg/kg once weekly s.c.

IMO-8400 1.2 mg/kg 2x/wk

IMO-8400 1.2 mg/kg twice weekly s.c.

IMO-8400 2.4 mg/kg 1x/wk

IMO-8400 2.4 mg/kg once weekly s.c.

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

Analysis denominator · Participants

GroupSource count
IMO-8400 0.6 mg/kg 1x/wk6
IMO-8400 1.2 mg/kg 1x/wk5
IMO-8400 1.2 mg/kg 2x/wk14
IMO-8400 2.4 mg/kg 1x/wk6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMO-8400 0.6 mg/kg 1x/wk0Not reportedNot reportedNot reportedNot reported
IMO-8400 1.2 mg/kg 1x/wk0Not reportedNot reportedNot reportedNot reported
IMO-8400 1.2 mg/kg 2x/wk1Not reportedNot reportedNot reportedNot reported
IMO-8400 2.4 mg/kg 1x/wk0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      14
    4. group Id
      OG003
      value
      6
    units
    Participants
description
To identify an appropriate dose of IMO-8400 for further clinical evaluation via evaluation of DLT at each dose level
groups
  1. description
    IMO-8400 0.6 mg/kg once weekly s.c.
    id
    OG000
    title
    IMO-8400 0.6 mg/kg 1x/wk
  2. description
    IMO-8400 1.2 mg/kg once weekly s.c.
    id
    OG001
    title
    IMO-8400 1.2 mg/kg 1x/wk
  3. description
    IMO-8400 1.2 mg/kg twice weekly s.c.
    id
    OG002
    title
    IMO-8400 1.2 mg/kg 2x/wk
  4. description
    IMO-8400 2.4 mg/kg once weekly s.c.
    id
    OG003
    title
    IMO-8400 2.4 mg/kg 1x/wk
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Population
reporting Status
POSTED
time Frame
28 days
title
Identify the Number of Patients Experiencing DLTs at Each Dose Level
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice