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NCT02807454 · ADVERSE EVENTS

Adverse events

A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma · Source last updated 2023-02-21

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
All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Simon Stage 1: D2 Arm

Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.

17 / 3231 / 3211 / 32
PD3 Arm

Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles

2 / 55 / 54 / 5

Group identifiers: EG000: Simon Stage 1: D2 Arm · EG001: PD3 Arm

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
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Death
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    General physical health deterioration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Oedema peripheral
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Pyrexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Hepatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Cellulitis streptococcal
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Corynebacterium infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Influenza
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Neutropenic sepsis

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
    24.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      5
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      5
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Cataract
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    term
    Conjunctival irritation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    term
    Ophthalmic vein thrombosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Abdominal pain upper
Complete source fields
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    32
    description
    Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator's discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.
    id
    EG000
    other Num Affected
    31
    other Num At Risk
    32
    serious Num Affected
    17
    serious Num At Risk
    32
    title
    Simon Stage 1: D2 Arm
  2. deaths Num Affected
    4
    deaths Num At Risk
    5
    description
    Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    PD3 Arm
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      5
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      5
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      5
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Cataract
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    term
    Conjunctival irritation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    term
    Ophthalmic vein thrombosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Abdominal pain upper
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Death
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    General physical health deterioration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Oedema peripheral
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Pyrexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Hepatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Cellulitis streptococcal
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Corynebacterium infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Influenza
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    term
    Neutropenic sepsis
time Frame
All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).

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