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NCT01324947 · ADVERSE EVENTS

Adverse events

Study to Evaluate the Safety and Efficacy of Pomalidomide Monotherapy in Subjects With Refractory or Relapsed Refractory Multiple Myeloma · Source last updated 2019-11-19

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
From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pomalidomide

Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity

52 / 7368 / 73Not reported / Not reported

Group identifiers: EG000: Pomalidomide

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
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      73
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      73
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      73
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      73
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    term
    Bronchitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      73
    term
    Bronchopneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      73
    term
    Neutropenic sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      73
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      73
    term
    Pulmonary embolism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      73
    term
    Lung disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    term
    Diabetic ketoacidosis

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
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      73
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      73
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      73
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      73
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      73
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      73
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      73
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      73
    term
    Oedema peripheral
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      73
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      73
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      73
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      73
    term
    Vomiting
Complete source fields
event Groups
  1. description
    Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
    id
    EG000
    other Num Affected
    68
    other Num At Risk
    73
    serious Num Affected
    52
    serious Num At Risk
    73
    title
    Pomalidomide
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      73
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      73
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      73
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      73
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      73
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      73
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      73
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      73
    term
    Oedema peripheral
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      73
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      73
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      73
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      73
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      73
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      73
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      73
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      73
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    term
    Bronchitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      73
    term
    Bronchopneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      73
    term
    Neutropenic sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      73
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      73
    term
    Pulmonary embolism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      73
    term
    Lung disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 14.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
    term
    Diabetic ketoacidosis
time Frame
From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.

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