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NCT03201965 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis · Source last updated 2025-11-26

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: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
Other-event reporting threshold
5%

All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Run-In: Daratumumab Plus CyBorD

Participants received the combination therapy during Run-in phase starting with 20 milligrams (mg) dexamethasone as premedication followed by daratumumab 1800 mg on Day 1 Cycle 1, then cyclophosphamide 300 milligram per meter square (mg/m\^2) orally or intravenous (IV) maximum weekly dose 500 mg, followed by bortezomib 1.3 mg/m\^2 subcutaneous (SC) injection once every week and dexamethasone remaining 20 mg post daratumumab dosing for up to 1 cycle (28 Days) to assess the safety before randomizing participants in CyBorD or daratumumab plus CyBorD arms. However, participants also continued daratumumab plus CyBorD for up to 6 cycles and then daratumumab monotherapy for up to 24 months from the start of treatment. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).

12 / 2827 / 2811 / 28
CyBorD

Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).

68 / 188181 / 18867 / 193
Daratumumab Plus CyBorD

Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).

91 / 193184 / 19347 / 195

Group identifiers: EG000: Run-In: Daratumumab Plus CyBorD · EG001: CyBorD · EG002: Daratumumab Plus CyBorD

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 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      193
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      193
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      193
    term
    Haemorrhagic Diathesis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      193
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      193
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      193
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      193
    term
    Acute Left Ventricular Failure
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      193
    term
    Acute Myocardial Infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      193
    term
    Angina Pectoris
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      193
    term
    Arrhythmia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      193
    term
    Arteriospasm Coronary
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      193
    term
    Atrial Fibrillation

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 22.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      49
      num At Risk
      193
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      193
    term
    Eosinopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      193
    term
    Leukocytosis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      193
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      193
    term
    Lymphopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      193
    term
    Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      193
    term
    Thrombocytopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      193
    term
    Palpitations
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      193
    term
    Tinnitus
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      193
    term
    Dry Eye
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      193
    term
    Ocular Hyperaemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      193
    term
    Vision Blurred
Complete source fields
description
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    28
    description
    Participants received the combination therapy during Run-in phase starting with 20 milligrams (mg) dexamethasone as premedication followed by daratumumab 1800 mg on Day 1 Cycle 1, then cyclophosphamide 300 milligram per meter square (mg/m\^2) orally or intravenous (IV) maximum weekly dose 500 mg, followed by bortezomib 1.3 mg/m\^2 subcutaneous (SC) injection once every week and dexamethasone remaining 20 mg post daratumumab dosing for up to 1 cycle (28 Days) to assess the safety before randomizing participants in CyBorD or daratumumab plus CyBorD arms. However, participants also continued daratumumab plus CyBorD for up to 6 cycles and then daratumumab monotherapy for up to 24 months from the start of treatment. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
    id
    EG000
    other Num Affected
    27
    other Num At Risk
    28
    serious Num Affected
    12
    serious Num At Risk
    28
    title
    Run-In: Daratumumab Plus CyBorD
  2. deaths Num Affected
    67
    deaths Num At Risk
    193
    description
    Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
    id
    EG001
    other Num Affected
    181
    other Num At Risk
    188
    serious Num Affected
    68
    serious Num At Risk
    188
    title
    CyBorD
  3. deaths Num Affected
    47
    deaths Num At Risk
    195
    description
    Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
    id
    EG002
    other Num Affected
    184
    other Num At Risk
    193
    serious Num Affected
    91
    serious Num At Risk
    193
    title
    Daratumumab Plus CyBorD
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      49
      num At Risk
      193
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      193
    term
    Eosinopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      193
    term
    Leukocytosis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      193
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      193
    term
    Lymphopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      193
    term
    Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      193
    term
    Thrombocytopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      193
    term
    Palpitations
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      193
    term
    Tinnitus
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      193
    term
    Dry Eye
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      193
    term
    Ocular Hyperaemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      193
    term
    Vision Blurred
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      193
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      193
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      193
    term
    Haemorrhagic Diathesis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      193
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      193
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      193
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      193
    term
    Acute Left Ventricular Failure
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      193
    term
    Acute Myocardial Infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      193
    term
    Angina Pectoris
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      193
    term
    Arrhythmia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      193
    term
    Arteriospasm Coronary
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      188
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      193
    term
    Atrial Fibrillation
time Frame
All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).

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Preserved source evidence · Not medical advice