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NCT01794520 · OUTCOME

Number of Participants With Adverse Events

Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2023-04-10

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
From first dose of study drug until 30 days following last dose of study drug (up to 2482 days)

What was measured

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

Analysis population: Safety population: all participants who received at least one dose of study drug

Groups in this outcome

Phase 1: Venetoclax 300 mg

Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.

Phase 1: Venetoclax 600 mg

Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.

Phase 1: Venetoclax 900 mg

Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.

Phase 1: Venetoclax 1200 mg

Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.

Phase 1 Safety Expansion: Venetoclax 1200 mg

Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.

Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg

Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).

Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg

The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).

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

Analysis denominator · Participants

GroupSource count
Phase 1: Venetoclax 300 mg6
Phase 1: Venetoclax 600 mg9
Phase 1: Venetoclax 900 mg6
Phase 1: Venetoclax 1200 mg9
Phase 1 Safety Expansion: Venetoclax 1200 mg36
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg20
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg31

Reported measurements

Any TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Venetoclax 300 mg6Not reportedNot reportedNot reportedNot reported
Phase 1: Venetoclax 600 mg9Not reportedNot reportedNot reportedNot reported
Phase 1: Venetoclax 900 mg6Not reportedNot reportedNot reportedNot reported
Phase 1: Venetoclax 1200 mg9Not reportedNot reportedNot reportedNot reported
Phase 1 Safety Expansion: Venetoclax 1200 mg36Not reportedNot reportedNot reportedNot reported
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg19Not reportedNot reportedNot reportedNot reported
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg30Not reportedNot reportedNot reportedNot reported
TESAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Venetoclax 300 mg1Not reportedNot reportedNot reportedNot reported
Phase 1: Venetoclax 600 mg4Not reportedNot reportedNot reportedNot reported
Phase 1: Venetoclax 900 mg3Not reportedNot reportedNot reportedNot reported
Phase 1: Venetoclax 1200 mg3Not reportedNot reportedNot reportedNot reported
Phase 1 Safety Expansion: Venetoclax 1200 mg15Not reportedNot reportedNot reportedNot reported
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg6Not reportedNot reportedNot reportedNot reported
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg16Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        36
      6. group Id
        OG005
        value
        19
      7. group Id
        OG006
        value
        30
    title
    Any TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        6
      7. group Id
        OG006
        value
        16
    title
    TESAE
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      9
    5. group Id
      OG004
      value
      36
    6. group Id
      OG005
      value
      20
    7. group Id
      OG006
      value
      31
    units
    Participants
description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
groups
  1. description
    Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
    id
    OG000
    title
    Phase 1: Venetoclax 300 mg
  2. description
    Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
    id
    OG001
    title
    Phase 1: Venetoclax 600 mg
  3. description
    Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
    id
    OG002
    title
    Phase 1: Venetoclax 900 mg
  4. description
    Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
    id
    OG003
    title
    Phase 1: Venetoclax 1200 mg
  5. description
    Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
    id
    OG004
    title
    Phase 1 Safety Expansion: Venetoclax 1200 mg
  6. description
    Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
    id
    OG005
    title
    Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
  7. description
    The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
    id
    OG006
    title
    Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population: all participants who received at least one dose of study drug
reporting Status
POSTED
time Frame
From first dose of study drug until 30 days following last dose of study drug (up to 2482 days)
title
Number of Participants With Adverse Events
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice