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NCT03710603 · ADVERSE EVENTS

Adverse events

Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma · Source last updated 2026-02-10

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
AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
Other-event reporting threshold
5%

All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Velcade Lenalidomide Dexamethasone (VRd)

Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.

171 / 347341 / 34744 / 354
Daratumumab + VRd (D-VRd)

Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.

200 / 351348 / 35134 / 355

Group identifiers: EG000: Velcade Lenalidomide Dexamethasone (VRd) · EG001: Daratumumab + VRd (D-VRd)

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      351
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      351
    term
    Febrile Bone Marrow Aplasia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      351
    term
    Febrile Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
    term
    Immune Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      351
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
    term
    Thrombotic Microangiopathy
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
    term
    Acute Coronary Syndrome
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      351
    term
    Acute Myocardial Infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
    term
    Angina Pectoris
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      351
    term
    Atrial Fibrillation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
    term
    Atrial Flutter
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      351
    term
    Cardiac Amyloidosis

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 Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      351
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      351
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      351
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      351
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      204
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      241
      num At Risk
      351
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      119
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      170
      num At Risk
      351
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      351
    term
    Abdominal Pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      351
    term
    Abdominal Pain Upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      118
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      118
      num At Risk
      351
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      185
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      213
      num At Risk
      351
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      351
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      351
    term
    Nausea
Complete source fields
description
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
event Groups
  1. deaths Num Affected
    44
    deaths Num At Risk
    354
    description
    Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
    id
    EG000
    other Num Affected
    341
    other Num At Risk
    347
    serious Num Affected
    171
    serious Num At Risk
    347
    title
    Velcade Lenalidomide Dexamethasone (VRd)
  2. deaths Num Affected
    34
    deaths Num At Risk
    355
    description
    Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
    id
    EG001
    other Num Affected
    348
    other Num At Risk
    351
    serious Num Affected
    200
    serious Num At Risk
    351
    title
    Daratumumab + VRd (D-VRd)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      351
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      351
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      351
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      351
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      204
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      241
      num At Risk
      351
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      119
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      170
      num At Risk
      351
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      351
    term
    Abdominal Pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      351
    term
    Abdominal Pain Upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      118
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      118
      num At Risk
      351
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      185
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      213
      num At Risk
      351
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      351
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      351
    term
    Nausea
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      351
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      351
    term
    Febrile Bone Marrow Aplasia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      351
    term
    Febrile Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
    term
    Immune Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      351
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
    term
    Thrombotic Microangiopathy
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
    term
    Acute Coronary Syndrome
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      351
    term
    Acute Myocardial Infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
    term
    Angina Pectoris
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      351
    term
    Atrial Fibrillation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      351
    term
    Atrial Flutter
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      347
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      351
    term
    Cardiac Amyloidosis
time Frame
AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.

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