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NCT02092909 · OUTCOME

Best Overall Response

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
Up to 24 weeks

What was measured

Best Overall Response using criteria from the VIth International Workshop in Waldenstrom's Macroglobulinemia

Analysis population: Efficacy Evaluable 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/wk5
IMO-8400 1.2 mg/kg 1x/wk4
IMO-8400 1.2 mg/kg 2x/wk12
IMO-8400 2.4 mg/kg 1x/wk5

Reported measurements

Source class 1

Complete Response

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/wk0Not reportedNot reportedNot reportedNot reported
IMO-8400 2.4 mg/kg 1x/wk0Not reportedNot reportedNot reportedNot reported

Very Good Partial Response

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/wk0Not reportedNot reportedNot reportedNot reported
IMO-8400 2.4 mg/kg 1x/wk0Not reportedNot reportedNot reportedNot reported

Partial Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMO-8400 0.6 mg/kg 1x/wk1Not reportedNot reportedNot reportedNot reported
IMO-8400 1.2 mg/kg 1x/wk0Not reportedNot reportedNot reportedNot reported
IMO-8400 1.2 mg/kg 2x/wk2Not reportedNot reportedNot reportedNot reported
IMO-8400 2.4 mg/kg 1x/wk0Not reportedNot reportedNot reportedNot reported

Minor Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMO-8400 0.6 mg/kg 1x/wk2Not reportedNot reportedNot reportedNot reported
IMO-8400 1.2 mg/kg 1x/wk0Not reportedNot reportedNot reportedNot reported
IMO-8400 1.2 mg/kg 2x/wk4Not reportedNot reportedNot reportedNot reported
IMO-8400 2.4 mg/kg 1x/wk1Not reportedNot reportedNot reportedNot reported

Standard Deviation

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMO-8400 0.6 mg/kg 1x/wk2Not reportedNot reportedNot reportedNot reported
IMO-8400 1.2 mg/kg 1x/wk3Not reportedNot reportedNot reportedNot reported
IMO-8400 1.2 mg/kg 2x/wk4Not reportedNot reportedNot reportedNot reported
IMO-8400 2.4 mg/kg 1x/wk3Not reportedNot reportedNot reportedNot reported

Progressive Disease

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/wk1Not reportedNot reportedNot reportedNot reported
IMO-8400 1.2 mg/kg 2x/wk1Not reportedNot reportedNot reportedNot reported
IMO-8400 2.4 mg/kg 1x/wk1Not reportedNot reportedNot reportedNot reported

Not Evaluable

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
        0
      4. group Id
        OG003
        value
        0
      title
      Complete Response
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      title
      Very Good Partial Response
    3. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
      title
      Partial Response
    4. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        1
      title
      Minor Response
    5. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        3
      title
      Standard Deviation
    6. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      title
      Progressive Disease
    7. 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
      title
      Not Evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      5
    units
    Participants
description
Best Overall Response using criteria from the VIth International Workshop in Waldenstrom's Macroglobulinemia
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
Efficacy Evaluable Population
reporting Status
POSTED
time Frame
Up to 24 weeks
title
Best Overall Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice