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NCT02951819 · ADVERSE EVENTS

Adverse events

A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma · Source last updated 2021-10-08

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
Up to 36 months
Other-event reporting threshold
0%

Safety analysis set is defined as enrolled participants who received at least 1 dose (partial or complete) of study treatment (Dara-CyBorD).

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

Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m\^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m\^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 (\[if with CyBorD\] Days 1,8,15,22). Consolidation therapy (CT): Participants who were considered eligible for transplant underwent autologous stem cell transplantation \[ASCT\] at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).

28 / 8686 / 869 / 86
Relapsed Multiple Myeloma (RMM)

Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m\^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m\^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 (\[if with CyBorD\] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).

5 / 1414 / 147 / 14

Group identifiers: EG000: Newly Diagnosed Multiple Myeloma (NDMM) · EG001: Relapsed Multiple Myeloma (RMM)

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Febrile Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Atrial Fibrillation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Atrial Flutter
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Haemorrhoidal Haemorrhage
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Non-Cardiac Chest Pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Pyrexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Cholecystitis Acute
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Bacteraemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Bacterial Sepsis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Bronchitis

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Hyperleukocytosis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Increased Tendency to Bruise
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Iron Deficiency Anaemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      14
    term
    Leukopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Lymphopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      14
    term
    Neutropenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      14
    term
    Thrombocytopenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Atrial Fibrillation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Atrial Flutter
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Bradycardia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Cardiac Failure Congestive
Complete source fields
description
Safety analysis set is defined as enrolled participants who received at least 1 dose (partial or complete) of study treatment (Dara-CyBorD).
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    86
    description
    Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m\^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m\^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 (\[if with CyBorD\] Days 1,8,15,22). Consolidation therapy (CT): Participants who were considered eligible for transplant underwent autologous stem cell transplantation \[ASCT\] at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
    id
    EG000
    other Num Affected
    86
    other Num At Risk
    86
    serious Num Affected
    28
    serious Num At Risk
    86
    title
    Newly Diagnosed Multiple Myeloma (NDMM)
  2. deaths Num Affected
    7
    deaths Num At Risk
    14
    description
    Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m\^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m\^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 (\[if with CyBorD\] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
    id
    EG001
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    5
    serious Num At Risk
    14
    title
    Relapsed Multiple Myeloma (RMM)
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Hyperleukocytosis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Increased Tendency to Bruise
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Iron Deficiency Anaemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      14
    term
    Leukopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Lymphopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      14
    term
    Neutropenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      14
    term
    Thrombocytopenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Atrial Fibrillation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Atrial Flutter
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Bradycardia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Cardiac Failure Congestive
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Febrile Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Atrial Fibrillation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Atrial Flutter
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
    term
    Haemorrhoidal Haemorrhage
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Non-Cardiac Chest Pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Pyrexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Cholecystitis Acute
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Bacteraemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Bacterial Sepsis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      86
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
    term
    Bronchitis
time Frame
Up to 36 months

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