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NCT04434469 · OUTCOME

Percentage of Participants With Adverse Events (AEs), Including Dose Limiting Toxicities (DLTs)

A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma · Source last updated 2024-07-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
Baseline up to 1 year 7 months

What was measured

Adverse event severity graded according to NCI CTCAE v5.0

Analysis population: Safety-Evaluable Patients

Groups in this outcome

Dose Escalation Cohort 1: RO7297089

Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit

Dose Escalation Cohort 2: RO7297089

Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit

Dose Escalation Cohort 3: RO7297089

Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit

Dose Escalation Cohort 4: RO7297089

Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit

Dose Escalation Backfill Cohort 4: RO7297089

Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.

Dose Escalation Cohort 5: RO7297089

Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.

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

Analysis denominator · Participants

GroupSource count
Dose Escalation Cohort 1: RO72970893
Dose Escalation Cohort 2: RO72970895
Dose Escalation Cohort 3: RO72970894
Dose Escalation Cohort 4: RO72970896
Dose Escalation Backfill Cohort 4: RO72970896
Dose Escalation Cohort 5: RO72970893

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation Cohort 1: RO7297089100Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort 2: RO7297089100Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort 3: RO729708975Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort 4: RO7297089100Not reportedNot reportedNot reportedNot reported
Dose Escalation Backfill Cohort 4: RO729708983.3Not reportedNot reportedNot reportedNot reported
Dose Escalation Cohort 5: RO7297089100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
      2. group Id
        OG001
        value
        100
      3. group Id
        OG002
        value
        75
      4. group Id
        OG003
        value
        100
      5. group Id
        OG004
        value
        83.3
      6. group Id
        OG005
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      3
    units
    Participants
description
Adverse event severity graded according to NCI CTCAE v5.0
groups
  1. description
    Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
    id
    OG000
    title
    Dose Escalation Cohort 1: RO7297089
  2. description
    Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
    id
    OG001
    title
    Dose Escalation Cohort 2: RO7297089
  3. description
    Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
    id
    OG002
    title
    Dose Escalation Cohort 3: RO7297089
  4. description
    Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
    id
    OG003
    title
    Dose Escalation Cohort 4: RO7297089
  5. description
    Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
    id
    OG004
    title
    Dose Escalation Backfill Cohort 4: RO7297089
  6. description
    Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
    id
    OG005
    title
    Dose Escalation Cohort 5: RO7297089
param Type
NUMBER
population Description
Safety-Evaluable Patients
reporting Status
POSTED
time Frame
Baseline up to 1 year 7 months
title
Percentage of Participants With Adverse Events (AEs), Including Dose Limiting Toxicities (DLTs)
type
PRIMARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice