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NCT00718419 · ADVERSE EVENTS

Adverse events

A Study for Patients That Have Been Previously Been Treated in Waldenstrom's Macroglobulinemia or Multiple Myeloma · Source last updated 2020-09-03

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%

Deaths due to progressive disease are not considered adverse events; however they are reported in the Participant Flow for those who died during the study and in the Other Pre-Specified Outcome Measure for those who died during the 30-day post study treatment follow-up period.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Multiple Myeloma (MM)

Participants diagnosed with MM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.

4 / 1412 / 14Not reported / Not reported
Waldenstrom's Macroglobulinemia (WM)

Participants diagnosed with WM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.

9 / 4242 / 42Not reported / Not reported

Group identifiers: EG000: Multiple Myeloma (MM) · EG001: Waldenstrom's Macroglobulinemia (WM)

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
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    This event resulted in death.
    organ System
    Cardiac disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Cardiac failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Intestinal obstruction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Peritoneal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Volvulus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Asthenia

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
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      14
      num Events
      6
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      42
      num Events
      15
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      42
      num Events
      8
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      42
      num Events
      6
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      42
      num Events
      7
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
      num Events
      3
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      14
      num Events
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
      num Events
      3
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      14
      num Events
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
      num Events
      2
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
      num Events
      2
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
      num Events
      3
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Chest pain
Complete source fields
description
Deaths due to progressive disease are not considered adverse events; however they are reported in the Participant Flow for those who died during the study and in the Other Pre-Specified Outcome Measure for those who died during the 30-day post study treatment follow-up period.
event Groups
  1. description
    Participants diagnosed with MM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    14
    serious Num Affected
    4
    serious Num At Risk
    14
    title
    Multiple Myeloma (MM)
  2. description
    Participants diagnosed with WM received: Three 125-milligrams (mg) Enzastaurin tablets three times on Day 1 of Cycle 1 (Day 1 total dose = 1125 mg). Day 2 onwards and subsequent Cycles: Two 125-mg tablets orally twice a day (500 mg total per day). Cycle length (all cycles): 28 days.
    id
    EG001
    other Num Affected
    42
    other Num At Risk
    42
    serious Num Affected
    9
    serious Num At Risk
    42
    title
    Waldenstrom's Macroglobulinemia (WM)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      14
      num Events
      6
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      42
      num Events
      15
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      42
      num Events
      8
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      42
      num Events
      6
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      42
      num Events
      7
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
      num Events
      3
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      14
      num Events
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
      num Events
      3
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      14
      num Events
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
      num Events
      2
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
      num Events
      2
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
      num Events
      3
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Chest pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    This event resulted in death.
    organ System
    Cardiac disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Cardiac failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    term
    Myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Intestinal obstruction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Peritoneal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Volvulus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Asthenia

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