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NCT00128921 · ADVERSE EVENTS

Adverse events

Study of Velcade® and Bone Formation in Patients With Relapsed/Refractory Multiple Myeloma · Source last updated 2012-04-26

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
The adverse event data was collected for a period of 1 year and 9 months, between 4/17/2006 to 12/26/2007
Other-event reporting threshold
0%

Adverse event data for cohort b was collected only for 6 participants, as 8 participants were enrolled but 2 did not start the protocol step

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bortezomib, Cohort a

treatment: 1.3 mg/m\^2

0 / 100 / 10Not reported / Not reported
Bortezomib, Cohort b

treatment: 1.0 mg/m\^2

1 / 60 / 6Not reported / Not reported
Bortezomib, Cohort c

treatment: 0.7 mg/m\^2

0 / 00 / 0Not reported / Not reported

Group identifiers: EG000: Bortezomib, Cohort a · EG001: Bortezomib, Cohort b · EG002: Bortezomib, Cohort c

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    unsteady gait and mental status changes

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Complete source fields
    description
    Adverse event data for cohort b was collected only for 6 participants, as 8 participants were enrolled but 2 did not start the protocol step
    event Groups
    1. description
      treatment: 1.3 mg/m\^2
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      10
      serious Num Affected
      0
      serious Num At Risk
      10
      title
      Bortezomib, Cohort a
    2. description
      treatment: 1.0 mg/m\^2
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      6
      serious Num Affected
      1
      serious Num At Risk
      6
      title
      Bortezomib, Cohort b
    3. description
      treatment: 0.7 mg/m\^2
      id
      EG002
      other Num Affected
      0
      other Num At Risk
      0
      serious Num Affected
      0
      serious Num At Risk
      0
      title
      Bortezomib, Cohort c
    frequency Threshold
    0
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        10
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        6
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      unsteady gait and mental status changes
    time Frame
    The adverse event data was collected for a period of 1 year and 9 months, between 4/17/2006 to 12/26/2007

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

    Preserved source evidence · Not medical advice