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NCT03412565 · ADVERSE EVENTS

Adverse events

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens · Source last updated 2025-04-29

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
For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months
Other-event reporting threshold
5%

All treated analysis set included all participants who received at least 1 dose of study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)

Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m\^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.

19 / 6767 / 671 / 67
D + Bortezomib + Melphalan + Prednisone (D-VMP)

Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; bortezomib 1.3 mg/m\^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m\^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m\^2 orally on Days 1 to 4 of cycles 1 to 9.

30 / 6767 / 673 / 67
Daratumumab + Lenalidomide + Dexamethasone (D-Rd)

Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months.

37 / 6565 / 654 / 65
Daratumumab + Carfilzomib + Dexamethasone (D-Kd)

Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m\^2 IV on Day 1 of Cycle 1 only, then 70 mg/m\^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months.

22 / 6666 / 665 / 66

Group identifiers: EG000: Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) · EG001: D + Bortezomib + Melphalan + Prednisone (D-VMP) · EG002: Daratumumab + Lenalidomide + Dexamethasone (D-Rd) · EG003: Daratumumab + Carfilzomib + Dexamethasone (D-Kd)

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 V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Arrhythmia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Atrial Fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Atrial Flutter
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      66
    term
    Cardiac Failure
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Cardiac Failure Congestive
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      66
    term
    Left Ventricular Dysfunction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Myocardial Infarction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Ophthalmic Vein Thrombosis

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 V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      66
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      66
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      66
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      66
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      34
      num At Risk
      66
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      66
    term
    Vertigo
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      66
    term
    Cataract
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      66
    term
    Abdominal Discomfort
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      66
    term
    Abdominal Pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      66
    term
    Abdominal Pain Upper
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      66
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      66
    term
    Diarrhoea
Complete source fields
description
All treated analysis set included all participants who received at least 1 dose of study treatment.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    67
    description
    Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m\^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
    id
    EG000
    other Num Affected
    67
    other Num At Risk
    67
    serious Num Affected
    19
    serious Num At Risk
    67
    title
    Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)
  2. deaths Num Affected
    3
    deaths Num At Risk
    67
    description
    Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; bortezomib 1.3 mg/m\^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m\^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m\^2 orally on Days 1 to 4 of cycles 1 to 9.
    id
    EG001
    other Num Affected
    67
    other Num At Risk
    67
    serious Num Affected
    30
    serious Num At Risk
    67
    title
    D + Bortezomib + Melphalan + Prednisone (D-VMP)
  3. deaths Num Affected
    4
    deaths Num At Risk
    65
    description
    Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months.
    id
    EG002
    other Num Affected
    65
    other Num At Risk
    65
    serious Num Affected
    37
    serious Num At Risk
    65
    title
    Daratumumab + Lenalidomide + Dexamethasone (D-Rd)
  4. deaths Num Affected
    5
    deaths Num At Risk
    66
    description
    Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m\^2 IV on Day 1 of Cycle 1 only, then 70 mg/m\^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months.
    id
    EG003
    other Num Affected
    66
    other Num At Risk
    66
    serious Num Affected
    22
    serious Num At Risk
    66
    title
    Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      66
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      66
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      66
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      66
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      34
      num At Risk
      66
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      66
    term
    Vertigo
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      66
    term
    Cataract
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      66
    term
    Abdominal Discomfort
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      66
    term
    Abdominal Pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      66
    term
    Abdominal Pain Upper
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      66
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      66
    term
    Diarrhoea
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Arrhythmia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Atrial Fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Atrial Flutter
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      66
    term
    Cardiac Failure
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Cardiac Failure Congestive
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      66
    term
    Left Ventricular Dysfunction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Myocardial Infarction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V21.1&23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      67
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      67
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      66
    term
    Ophthalmic Vein Thrombosis
time Frame
For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months

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Preserved source evidence · Not medical advice