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NCT00483262 · ADVERSE EVENTS

Adverse events

Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma · Source last updated 2013-11-11

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
June 2007 to December 2009
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Adverse Events CCI779 and Bortezomib Phase I

Adverse Events of CCI779 and Bortezomib in the phase I part of this phase I/II study.

13 / 2018 / 20Not reported / Not reported
Adverse Events CCI779 and Bortezomib Phase II

Adverse Events of CCI779 and Bortezomib in Phase II part of this Phase I/II study.

25 / 4334 / 43Not reported / Not reported

Group identifiers: EG000: Adverse Events CCI779 and Bortezomib Phase I · EG001: Adverse Events CCI779 and Bortezomib Phase II

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      43
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      43
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      43
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      43
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      43
    term
    Anemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      43
    term
    Diarrhea

Other reported 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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      20
      num Events
      19
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      43
      num Events
      36
    term
    Thromobocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      20
      num Events
      18
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      43
      num Events
      27
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      20
      num Events
      14
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      43
      num Events
      32
    term
    Leucopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      20
      num Events
      13
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      43
      num Events
      14
    term
    Hypertriglyceridaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      20
      num Events
      12
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      43
      num Events
      25
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      20
      num Events
      11
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      43
      num Events
      22
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      20
      num Events
      11
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      43
      num Events
      21
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      20
      num Events
      10
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      43
      num Events
      12
    term
    Hyperglycaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      20
      num Events
      10
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      43
      num Events
      26
    term
    Lymphopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      20
      num Events
      7
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      43
      num Events
      11
    term
    Hypercholesterolaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
      num Events
      6
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      43
      num Events
      15
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
      num Events
      5
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      43
      num Events
      10
    term
    Anorexia
Complete source fields
event Groups
  1. description
    Adverse Events of CCI779 and Bortezomib in the phase I part of this phase I/II study.
    id
    EG000
    other Num Affected
    18
    other Num At Risk
    20
    serious Num Affected
    13
    serious Num At Risk
    20
    title
    Adverse Events CCI779 and Bortezomib Phase I
  2. description
    Adverse Events of CCI779 and Bortezomib in Phase II part of this Phase I/II study.
    id
    EG001
    other Num Affected
    34
    other Num At Risk
    43
    serious Num Affected
    25
    serious Num At Risk
    43
    title
    Adverse Events CCI779 and Bortezomib Phase II
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      20
      num Events
      19
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      43
      num Events
      36
    term
    Thromobocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      20
      num Events
      18
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      43
      num Events
      27
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      20
      num Events
      14
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      43
      num Events
      32
    term
    Leucopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      20
      num Events
      13
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      43
      num Events
      14
    term
    Hypertriglyceridaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      20
      num Events
      12
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      43
      num Events
      25
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      20
      num Events
      11
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      43
      num Events
      22
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      20
      num Events
      11
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      43
      num Events
      21
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      20
      num Events
      10
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      43
      num Events
      12
    term
    Hyperglycaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      20
      num Events
      10
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      43
      num Events
      26
    term
    Lymphopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      20
      num Events
      7
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      43
      num Events
      11
    term
    Hypercholesterolaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
      num Events
      6
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      43
      num Events
      15
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
      num Events
      5
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      43
      num Events
      10
    term
    Anorexia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      43
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      43
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      43
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      43
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      43
    term
    Anemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      43
    term
    Diarrhea
time Frame
June 2007 to December 2009

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Preserved source evidence · Not medical advice