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NCT01985126 · ADVERSE EVENTS

Adverse events

An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD · Source last updated 2018-06-25

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
Approximately up to 3.8 years
Other-event reporting threshold
5%

All treated Analysis Set included all participants who received at least 1 dose of daratumumab.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Daratumumab 8 mg/kg

Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.

6 / 1818 / 18Not reported / Not reported
Daratumumab 16 mg/kg

Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.

33 / 106105 / 106Not reported / Not reported

Group identifiers: EG000: Daratumumab 8 mg/kg · EG001: Daratumumab 16 mg/kg

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Cardiac Failure Congestive
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Cardio-Respiratory Arrest
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Abdominal Pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Faecal Incontinence
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Large Intestinal Obstruction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Pancreatitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Vomiting
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Asthenia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Fatigue

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      106
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      106
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      106
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      106
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      106
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Sinus Tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      106
    term
    Tachycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Cerumen Impaction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Ear Discomfort
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Cataract
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      106
    term
    Abdominal Discomfort
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      106
    term
    Abdominal Distension
Complete source fields
description
All treated Analysis Set included all participants who received at least 1 dose of daratumumab.
event Groups
  1. description
    Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    6
    serious Num At Risk
    18
    title
    Daratumumab 8 mg/kg
  2. description
    Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    105
    other Num At Risk
    106
    serious Num Affected
    33
    serious Num At Risk
    106
    title
    Daratumumab 16 mg/kg
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      106
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      106
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      106
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      106
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      106
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Sinus Tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      106
    term
    Tachycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Cerumen Impaction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Ear Discomfort
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Cataract
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      106
    term
    Abdominal Discomfort
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      106
    term
    Abdominal Distension
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      106
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Cardiac Failure Congestive
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Cardio-Respiratory Arrest
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Abdominal Pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Faecal Incontinence
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Large Intestinal Obstruction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Pancreatitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      106
    term
    Vomiting
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Asthenia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      18
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      106
    term
    Fatigue
time Frame
Approximately up to 3.8 years

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