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NCT00287872 · ADVERSE EVENTS

Adverse events

Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma · Source last updated 2018-03-01

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
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bortezomib and Thalidomide

The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide. bortezomib thalidomide

10 / 3025 / 30Not reported / Not reported

Group identifiers: EG000: Bortezomib and Thalidomide

Serious adverse events

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

  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    dehydration
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    nausea & vomiting
  3. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    renal failure
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    neutropenic fever
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
      num Events
      3
    term
    pneumonia
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    hyperkalemia

Other reported adverse events

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

  1. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      30
      num Events
      75
    term
    peripheral neuropathy
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      30
      num Events
      7
    term
    hypotension
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      30
      num Events
      48
    term
    fatigue
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      30
      num Events
      40
    term
    constipation
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      30
      num Events
      29
    term
    diarrhoea
Complete source fields
event Groups
  1. description
    The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide. bortezomib thalidomide
    id
    EG000
    other Num Affected
    25
    other Num At Risk
    30
    serious Num Affected
    10
    serious Num At Risk
    30
    title
    Bortezomib and Thalidomide
frequency Threshold
5
other Events
  1. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      30
      num Events
      75
    term
    peripheral neuropathy
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      30
      num Events
      7
    term
    hypotension
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      30
      num Events
      48
    term
    fatigue
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      30
      num Events
      40
    term
    constipation
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      30
      num Events
      29
    term
    diarrhoea
serious Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    dehydration
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    nausea & vomiting
  3. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    renal failure
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    neutropenic fever
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
      num Events
      3
    term
    pneumonia
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    hyperkalemia

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Preserved source evidence · Not medical advice