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NCT03275285 · ADVERSE EVENTS

Adverse events

Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients · Source last updated 2026-02-09

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
AE data and deaths were collected during the whole study. TEAEs that developed, worsened, or became serious during the treatment period were assessed from first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to 349 weeks for Kd arm and 356 weeks for IKd arm (maximum duration of treatment exposure).
Other-event reporting threshold
5%

AEs and SAEs were collected in safety population that included participants who received at least 1 dose or a part of a dose of the study treatments. All-Cause Mortality data collected during the study was assessed for all randomized participants. All-cause mortality (deaths) was assessed from randomization to the end of follow-up (FU) for each participant. Maximum time between randomization and those deaths observed in FU was up to approximately 297 weeks.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Carfilzomib + Dexamethasone (Kd)

Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 349 weeks).

74 / 122113 / 12259 / 123
Isatuximab + Carfilzomib + Dexamethasone (IKd)

Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 356 weeks).

129 / 177167 / 17783 / 179

Group identifiers: EG000: Carfilzomib + Dexamethasone (Kd) · EG001: Isatuximab + Carfilzomib + Dexamethasone (IKd)

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 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Abdominal Abscess
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Abdominal Sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Appendicitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Atypical Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Bacterial Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      177
      num Events
      2
    term
    Bacterial Sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      177
      num Events
      3
    term
    Bronchitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Bronchitis Pneumococcal
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      177
      num Events
      5
    term
    Covid-19
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      122
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      177
      num Events
      4
    term
    Covid-19 Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Campylobacter Gastroenteritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      122
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      177
      num Events
      3
    term
    Cellulitis

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
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      122
      num Events
      22
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      177
      num Events
      71
    term
    Bronchitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      122
      num Events
      2
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      177
      num Events
      31
    term
    Covid-19
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      122
      num Events
      13
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      177
      num Events
      13
    term
    Conjunctivitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      122
      num Events
      7
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      177
      num Events
      23
    term
    Gastroenteritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      122
      num Events
      26
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      177
      num Events
      27
    term
    Influenza
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      122
      num Events
      12
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      177
      num Events
      16
    term
    Lower Respiratory Tract Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      122
      num Events
      30
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      177
      num Events
      51
    term
    Nasopharyngitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      122
      num Events
      21
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      177
      num Events
      21
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      122
      num Events
      10
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      177
      num Events
      49
    term
    Respiratory Tract Infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      122
      num Events
      4
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      177
      num Events
      18
    term
    Rhinitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      122
      num Events
      8
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      177
      num Events
      20
    term
    Sinusitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      122
      num Events
      51
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      177
      num Events
      189
    term
    Upper Respiratory Tract Infection
Complete source fields
description
AEs and SAEs were collected in safety population that included participants who received at least 1 dose or a part of a dose of the study treatments. All-Cause Mortality data collected during the study was assessed for all randomized participants. All-cause mortality (deaths) was assessed from randomization to the end of follow-up (FU) for each participant. Maximum time between randomization and those deaths observed in FU was up to approximately 297 weeks.
event Groups
  1. deaths Num Affected
    59
    deaths Num At Risk
    123
    description
    Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 349 weeks).
    id
    EG000
    other Num Affected
    113
    other Num At Risk
    122
    serious Num Affected
    74
    serious Num At Risk
    122
    title
    Carfilzomib + Dexamethasone (Kd)
  2. deaths Num Affected
    83
    deaths Num At Risk
    179
    description
    Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 356 weeks).
    id
    EG001
    other Num Affected
    167
    other Num At Risk
    177
    serious Num Affected
    129
    serious Num At Risk
    177
    title
    Isatuximab + Carfilzomib + Dexamethasone (IKd)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      122
      num Events
      22
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      177
      num Events
      71
    term
    Bronchitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      122
      num Events
      2
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      177
      num Events
      31
    term
    Covid-19
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      122
      num Events
      13
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      177
      num Events
      13
    term
    Conjunctivitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      122
      num Events
      7
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      177
      num Events
      23
    term
    Gastroenteritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      122
      num Events
      26
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      177
      num Events
      27
    term
    Influenza
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      122
      num Events
      12
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      177
      num Events
      16
    term
    Lower Respiratory Tract Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      122
      num Events
      30
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      177
      num Events
      51
    term
    Nasopharyngitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      122
      num Events
      21
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      177
      num Events
      21
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      122
      num Events
      10
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      177
      num Events
      49
    term
    Respiratory Tract Infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      122
      num Events
      4
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      177
      num Events
      18
    term
    Rhinitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      122
      num Events
      8
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      177
      num Events
      20
    term
    Sinusitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      122
      num Events
      51
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      177
      num Events
      189
    term
    Upper Respiratory Tract Infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Abdominal Abscess
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Abdominal Sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Appendicitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Atypical Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Bacterial Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      177
      num Events
      2
    term
    Bacterial Sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      177
      num Events
      3
    term
    Bronchitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Bronchitis Pneumococcal
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      177
      num Events
      5
    term
    Covid-19
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      122
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      177
      num Events
      4
    term
    Covid-19 Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Campylobacter Gastroenteritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      122
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      177
      num Events
      3
    term
    Cellulitis
time Frame
AE data and deaths were collected during the whole study. TEAEs that developed, worsened, or became serious during the treatment period were assessed from first dose of study treatment administration (Day 1) up to 30 days post last dose of study treatment administration, up to 349 weeks for Kd arm and 356 weeks for IKd arm (maximum duration of treatment exposure).

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