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NCT00473590 · OUTCOME

Number of Participants With Selected Adverse Events (AEs)

A Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (AMBER) · Source last updated 2017-06-14

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination (up to 122 weeks).

What was measured

Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All serious adverse events are listed in the Adverse Event Reporting section.

Analysis population: Safety population: all patients who were randomized and received any amount of study treatment. Two patients who randomized to the BORT + P arm received at least 1 dose of bevacizumab and were analyzed as bevacizumab-treated patients. Therefore, the safety analysis included 50 patients in the BORT + P arm and 50 patients in the BORT + BV arm.

Groups in this outcome

BORT + P

Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.

BORT + BV

Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.

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

Analysis denominator · Participants

GroupSource count
BORT + P50
BORT + BV50

Reported measurements

Arterial thromboembolic events (any grade)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BORT + P0Not reportedNot reportedNot reportedNot reported
BORT + BV1Not reportedNot reportedNot reportedNot reported
Bleeding other than pulmonary or CNS (Grade >=3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BORT + P1Not reportedNot reportedNot reportedNot reported
BORT + BV2Not reportedNot reportedNot reportedNot reported
Febrile neutropenia (any grade)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BORT + P1Not reportedNot reportedNot reportedNot reported
BORT + BV1Not reportedNot reportedNot reportedNot reported
Gastrointestinal Perforation (Any Grade)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BORT + P1Not reportedNot reportedNot reportedNot reported
BORT + BV0Not reportedNot reportedNot reportedNot reported
Hypertension (Grade >= 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BORT + P0Not reportedNot reportedNot reportedNot reported
BORT + BV8Not reportedNot reportedNot reportedNot reported
Left Ventricular Systolic Dysfunction (Grade >= 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BORT + P1Not reportedNot reportedNot reportedNot reported
BORT + BV0Not reportedNot reportedNot reportedNot reported
Neutropenia (Grade >= 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BORT + P6Not reportedNot reportedNot reportedNot reported
BORT + BV10Not reportedNot reportedNot reportedNot reported
Osteonecrosis of the Jaw
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BORT + P0Not reportedNot reportedNot reportedNot reported
BORT + BV1Not reportedNot reportedNot reportedNot reported
Peripheral Neuropathy (Grade >= 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BORT + P7Not reportedNot reportedNot reportedNot reported
BORT + BV8Not reportedNot reportedNot reportedNot reported
Pulmonary and CNS Bleeding (Any Grade)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BORT + P0Not reportedNot reportedNot reportedNot reported
BORT + BV1Not reportedNot reportedNot reportedNot reported
Thrombocytopenia (Grade >= 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BORT + P15Not reportedNot reportedNot reportedNot reported
BORT + BV15Not reportedNot reportedNot reportedNot reported
Vernous Thromboembolic Events (Grade >=3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BORT + P1Not reportedNot reportedNot reportedNot reported
BORT + BV0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Arterial thromboembolic events (any grade)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
    title
    Bleeding other than pulmonary or CNS (Grade >=3)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Febrile neutropenia (any grade)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Gastrointestinal Perforation (Any Grade)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        8
    title
    Hypertension (Grade >= 3)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Left Ventricular Systolic Dysfunction (Grade >= 3)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        10
    title
    Neutropenia (Grade >= 3)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Osteonecrosis of the Jaw
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        8
    title
    Peripheral Neuropathy (Grade >= 3)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Pulmonary and CNS Bleeding (Any Grade)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        15
    title
    Thrombocytopenia (Grade >= 3)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Vernous Thromboembolic Events (Grade >=3)
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    2. group Id
      OG001
      value
      50
    units
    Participants
description
Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All serious adverse events are listed in the Adverse Event Reporting section.
groups
  1. description
    Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
    id
    OG000
    title
    BORT + P
  2. description
    Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
    id
    OG001
    title
    BORT + BV
param Type
NUMBER
population Description
Safety population: all patients who were randomized and received any amount of study treatment. Two patients who randomized to the BORT + P arm received at least 1 dose of bevacizumab and were analyzed as bevacizumab-treated patients. Therefore, the safety analysis included 50 patients in the BORT + P arm and 50 patients in the BORT + BV arm.
reporting Status
POSTED
time Frame
Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination (up to 122 weeks).
title
Number of Participants With Selected Adverse Events (AEs)
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice