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NCT00657553 · ADVERSE EVENTS

Adverse events

Preemptive Strike With Bortezomib in Multiple Myeloma Patients · Source last updated 2017-11-20

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
Not reported
Other-event reporting threshold
0%

there were no events reported in the five participants enrolled in the treatment arm or in the five participants enrolled in the observation arm of this study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment Arm

Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3

0 / 50 / 5Not reported / Not reported
Observation Arm

Patients will be observed for progress over the course of three years.

0 / 50 / 5Not reported / Not reported

Group identifiers: EG000: Treatment Arm · EG001: Observation Arm

Serious adverse events

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

    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
      there were no events reported in the five participants enrolled in the treatment arm or in the five participants enrolled in the observation arm of this study.
      event Groups
      1. description
        Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        5
        serious Num Affected
        0
        serious Num At Risk
        5
        title
        Treatment Arm
      2. description
        Patients will be observed for progress over the course of three years.
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        5
        serious Num Affected
        0
        serious Num At Risk
        5
        title
        Observation Arm
      frequency Threshold
      0

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

      Preserved source evidence · Not medical advice