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NCT02092909 · OUTCOME

Safety and Tolerability of IMO-8400 in Patients With Waldenstrom's Macroglobulinemia

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

Safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia: Assessment of adverse events

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

At Least 1 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMO-8400 0.6 mg/kg 1x/wk6Not reportedNot reportedNot reportedNot reported
IMO-8400 1.2 mg/kg 1x/wk5Not reportedNot reportedNot reportedNot reported
IMO-8400 1.2 mg/kg 2x/wk14Not reportedNot reportedNot reportedNot reported
IMO-8400 2.4 mg/kg 1x/wk6Not reportedNot reportedNot reportedNot reported
At Least 1 Related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMO-8400 0.6 mg/kg 1x/wk5Not reportedNot reportedNot reportedNot reported
IMO-8400 1.2 mg/kg 1x/wk2Not reportedNot reportedNot reportedNot reported
IMO-8400 1.2 mg/kg 2x/wk12Not reportedNot reportedNot reportedNot reported
IMO-8400 2.4 mg/kg 1x/wk6Not reportedNot reportedNot reportedNot reported
At Least 1 Grade >=3 TEAE
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/wk2Not reportedNot reportedNot reportedNot reported
IMO-8400 1.2 mg/kg 2x/wk7Not reportedNot reportedNot reportedNot reported
IMO-8400 2.4 mg/kg 1x/wk3Not reportedNot reportedNot reportedNot reported
At Least 1 SAE
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/wk2Not reportedNot reportedNot reportedNot reported
At Least 1 DLT
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
At Least 1 TEAE Leading to Death
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
At Least 1 TEAE Leading to Premature Treatment DC
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/wk4Not reportedNot reportedNot reportedNot reported
IMO-8400 2.4 mg/kg 1x/wk2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        14
      4. group Id
        OG003
        value
        6
    title
    At Least 1 TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        6
    title
    At Least 1 Related TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        3
    title
    At Least 1 Grade >=3 TEAE
  4. 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
        2
    title
    At Least 1 SAE
  5. 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
    title
    At Least 1 DLT
  6. 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
    At Least 1 TEAE Leading to Death
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        2
    title
    At Least 1 TEAE Leading to Premature Treatment DC
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
Safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia: Assessment of adverse events
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
Up to 24 weeks
title
Safety and Tolerability of IMO-8400 in Patients With Waldenstrom's Macroglobulinemia
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice