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NCT02963493 · ADVERSE EVENTS

Adverse events

A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2022-11-22

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
Patients were treated in 28 day cycles indefinitely until withdrawal from study, with the longest time on study of 17 months. Adverse events were collected until 30 days after the last dose of study drug. Patients were followed for survival for 24 months after disease progression or start of subsequent anti-myeloma therapy.
Other-event reporting threshold
5%

The Safety Analysis Set for evaluation of adverse events included all patients who received at least one dose of melflufen or dexamethasone in the study. Patients that were triple-class refractory and those with extramedullary disease were defined as a subgroups of interest for evaluation.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set

Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle. Melphalan flufenamide (Melflufen) Dexamethasone: IV dexamethasone may be substituted for oral dexamethasone in the US. Oral only in Europe.

88 / 157157 / 157130 / 157
Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease

Patients with extramedullary disease at baseline defined as myeloma disease either originating in, but extending beyond, the cortical bone or as a separate soft tissue mass.

38 / 5555 / 5551 / 55
Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease

Triple class refractory population defined as refractory to or intolerant of at least one immunomodulatory drug, at least one proteasome inhibitor, and at least one anti-CD38 monoclonal antibody.

70 / 119119 / 119105 / 119

Group identifiers: EG000: Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set · EG001: Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease · EG002: Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      157
      num Events
      16
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      55
      num Events
      6
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      119
      num Events
      8
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      157
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      119
      num Events
      4
    term
    Respiratory tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      157
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      119
      num Events
      2
    term
    Bronchitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      157
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      119
      num Events
      3
    term
    Clostridium difficile infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      157
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      119
      num Events
      2
    term
    Influenza
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      157
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      119
      num Events
      1
    term
    Sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      157
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      119
      num Events
      2
    term
    Soft tissue infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      157
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      119
      num Events
      0
    term
    Upper respiratory tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      157
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      119
      num Events
      2
    term
    Viral upper respiratory tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      157
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
      num Events
      4
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      119
      num Events
      8
    term
    Febrile neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      157
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
      num Events
      4
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      119
      num Events
      6
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      157
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      119
      num Events
      2
    term
    Neutropenia

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 19.1
    stats
    1. group Id
      EG000
      num Affected
      113
      num At Risk
      157
      num Events
      432
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      55
      num Events
      154
    3. group Id
      EG002
      num Affected
      78
      num At Risk
      119
      num Events
      300
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      157
      num Events
      628
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      55
      num Events
      130
    3. group Id
      EG002
      num Affected
      64
      num At Risk
      119
      num Events
      415
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      86
      num At Risk
      157
      num Events
      549
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      55
      num Events
      126
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      119
      num Events
      374
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      157
      num Events
      53
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
      num Events
      11
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      119
      num Events
      41
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      157
      num Events
      77
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
      num Events
      44
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      119
      num Events
      65
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      157
      num Events
      74
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      55
      num Events
      24
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      119
      num Events
      56
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      157
      num Events
      73
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      55
      num Events
      22
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      119
      num Events
      50
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      157
      num Events
      64
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      55
      num Events
      11
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      119
      num Events
      49
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      157
      num Events
      25
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      55
      num Events
      11
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      119
      num Events
      14
    term
    Oedema peripheral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      157
      num Events
      67
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      55
      num Events
      19
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      119
      num Events
      53
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      157
      num Events
      67
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      55
      num Events
      21
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      119
      num Events
      45
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      157
      num Events
      26
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      55
      num Events
      13
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      119
      num Events
      22
    term
    Constipation
Complete source fields
description
The Safety Analysis Set for evaluation of adverse events included all patients who received at least one dose of melflufen or dexamethasone in the study. Patients that were triple-class refractory and those with extramedullary disease were defined as a subgroups of interest for evaluation.
event Groups
  1. deaths Num Affected
    130
    deaths Num At Risk
    157
    description
    Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle. Melphalan flufenamide (Melflufen) Dexamethasone: IV dexamethasone may be substituted for oral dexamethasone in the US. Oral only in Europe.
    id
    EG000
    other Num Affected
    157
    other Num At Risk
    157
    serious Num Affected
    88
    serious Num At Risk
    157
    title
    Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set
  2. deaths Num Affected
    51
    deaths Num At Risk
    55
    description
    Patients with extramedullary disease at baseline defined as myeloma disease either originating in, but extending beyond, the cortical bone or as a separate soft tissue mass.
    id
    EG001
    other Num Affected
    55
    other Num At Risk
    55
    serious Num Affected
    38
    serious Num At Risk
    55
    title
    Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease
  3. deaths Num Affected
    105
    deaths Num At Risk
    119
    description
    Triple class refractory population defined as refractory to or intolerant of at least one immunomodulatory drug, at least one proteasome inhibitor, and at least one anti-CD38 monoclonal antibody.
    id
    EG002
    other Num Affected
    119
    other Num At Risk
    119
    serious Num Affected
    70
    serious Num At Risk
    119
    title
    Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      113
      num At Risk
      157
      num Events
      432
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      55
      num Events
      154
    3. group Id
      EG002
      num Affected
      78
      num At Risk
      119
      num Events
      300
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      157
      num Events
      628
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      55
      num Events
      130
    3. group Id
      EG002
      num Affected
      64
      num At Risk
      119
      num Events
      415
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      86
      num At Risk
      157
      num Events
      549
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      55
      num Events
      126
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      119
      num Events
      374
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      157
      num Events
      53
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
      num Events
      11
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      119
      num Events
      41
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      157
      num Events
      77
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
      num Events
      44
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      119
      num Events
      65
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      157
      num Events
      74
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      55
      num Events
      24
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      119
      num Events
      56
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      157
      num Events
      73
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      55
      num Events
      22
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      119
      num Events
      50
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      157
      num Events
      64
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      55
      num Events
      11
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      119
      num Events
      49
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      157
      num Events
      25
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      55
      num Events
      11
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      119
      num Events
      14
    term
    Oedema peripheral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      157
      num Events
      67
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      55
      num Events
      19
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      119
      num Events
      53
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      157
      num Events
      67
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      55
      num Events
      21
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      119
      num Events
      45
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      157
      num Events
      26
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      55
      num Events
      13
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      119
      num Events
      22
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      157
      num Events
      16
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      55
      num Events
      6
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      119
      num Events
      8
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      157
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      119
      num Events
      4
    term
    Respiratory tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      157
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      119
      num Events
      2
    term
    Bronchitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      157
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      119
      num Events
      3
    term
    Clostridium difficile infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      157
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      119
      num Events
      2
    term
    Influenza
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      157
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      119
      num Events
      1
    term
    Sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      157
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      119
      num Events
      2
    term
    Soft tissue infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      157
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      119
      num Events
      0
    term
    Upper respiratory tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      157
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      119
      num Events
      2
    term
    Viral upper respiratory tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      157
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
      num Events
      4
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      119
      num Events
      8
    term
    Febrile neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      157
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
      num Events
      4
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      119
      num Events
      6
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      157
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      119
      num Events
      2
    term
    Neutropenia
time Frame
Patients were treated in 28 day cycles indefinitely until withdrawal from study, with the longest time on study of 17 months. Adverse events were collected until 30 days after the last dose of study drug. Patients were followed for survival for 24 months after disease progression or start of subsequent anti-myeloma therapy.

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Preserved source evidence · Not medical advice