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NCT02990338 · ADVERSE EVENTS

Adverse events

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients · Source last updated 2025-01-17

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 was collected from the time of first dose of study drug administration up to 30 days following the last administration of study treatment (maximum duration up to 306.6 weeks for Pd arm and 311.0 weeks for IPd arm). Per participant, the deaths were collected up to a maximum duration of approximately 72.38 months.
Other-event reporting threshold
5%

All-Cause Mortality was assessed for all randomized participants, Serious and Other Adverse Events were collected for safety population only.

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

Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 306.6 weeks).

91 / 149139 / 149115 / 153
IPd (Isatuximab + Pomalidomide + Dexamethasone)

Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 311.0 weeks).

112 / 152145 / 152110 / 154

Group identifiers: EG000: Pd (Pomalidomide + Dexamethasone) · EG001: IPd (Isatuximab + Pomalidomide + Dexamethasone)

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      152
      num Events
      1
    term
    Acarodermatitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      152
      num Events
      2
    term
    Atypical Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      152
      num Events
      2
    term
    Bronchiolitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
      num Events
      1
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      152
      num Events
      8
    term
    Bronchitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      149
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
      num Events
      0
    term
    Covid-19
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      149
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      152
      num Events
      2
    term
    Covid-19 Pneumonia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
      num Events
      0
    term
    Candida Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      152
      num Events
      1
    term
    Cellulitis Staphylococcal
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      152
      num Events
      1
    term
    Coronavirus Infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
      num Events
      0
    term
    Cytomegalovirus Gastrointestinal Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      152
      num Events
      1
    term
    Device Related Sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      152
      num Events
      2
    term
    Diverticulitis

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      149
      num Events
      29
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      152
      num Events
      65
    term
    Bronchitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      149
      num Events
      7
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      152
      num Events
      9
    term
    Influenza
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      149
      num Events
      13
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      152
      num Events
      44
    term
    Nasopharyngitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      149
      num Events
      3
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      152
      num Events
      18
    term
    Oral Herpes
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      149
      num Events
      10
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      152
      num Events
      29
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      149
      num Events
      51
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      152
      num Events
      121
    term
    Upper Respiratory Tract Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      149
      num Events
      15
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      152
      num Events
      21
    term
    Urinary Tract Infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      152
      num Events
      10
    term
    Febrile Neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      149
      num Events
      96
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      152
      num Events
      192
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      149
      num Events
      19
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      152
      num Events
      27
    term
    Thrombocytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      149
      num Events
      9
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      152
      num Events
      23
    term
    Decreased Appetite
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      149
      num Events
      17
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      152
      num Events
      17
    term
    Insomnia
Complete source fields
description
All-Cause Mortality was assessed for all randomized participants, Serious and Other Adverse Events were collected for safety population only.
event Groups
  1. deaths Num Affected
    115
    deaths Num At Risk
    153
    description
    Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 306.6 weeks).
    id
    EG000
    other Num Affected
    139
    other Num At Risk
    149
    serious Num Affected
    91
    serious Num At Risk
    149
    title
    Pd (Pomalidomide + Dexamethasone)
  2. deaths Num Affected
    110
    deaths Num At Risk
    154
    description
    Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 311.0 weeks).
    id
    EG001
    other Num Affected
    145
    other Num At Risk
    152
    serious Num Affected
    112
    serious Num At Risk
    152
    title
    IPd (Isatuximab + Pomalidomide + Dexamethasone)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      149
      num Events
      29
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      152
      num Events
      65
    term
    Bronchitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      149
      num Events
      7
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      152
      num Events
      9
    term
    Influenza
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      149
      num Events
      13
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      152
      num Events
      44
    term
    Nasopharyngitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      149
      num Events
      3
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      152
      num Events
      18
    term
    Oral Herpes
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      149
      num Events
      10
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      152
      num Events
      29
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      149
      num Events
      51
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      152
      num Events
      121
    term
    Upper Respiratory Tract Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      149
      num Events
      15
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      152
      num Events
      21
    term
    Urinary Tract Infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      152
      num Events
      10
    term
    Febrile Neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      149
      num Events
      96
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      152
      num Events
      192
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      149
      num Events
      19
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      152
      num Events
      27
    term
    Thrombocytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      149
      num Events
      9
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      152
      num Events
      23
    term
    Decreased Appetite
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      149
      num Events
      17
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      152
      num Events
      17
    term
    Insomnia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      152
      num Events
      1
    term
    Acarodermatitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      152
      num Events
      2
    term
    Atypical Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      152
      num Events
      2
    term
    Bronchiolitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
      num Events
      1
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      152
      num Events
      8
    term
    Bronchitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      149
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
      num Events
      0
    term
    Covid-19
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      149
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      152
      num Events
      2
    term
    Covid-19 Pneumonia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
      num Events
      0
    term
    Candida Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      152
      num Events
      1
    term
    Cellulitis Staphylococcal
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      152
      num Events
      1
    term
    Coronavirus Infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
      num Events
      0
    term
    Cytomegalovirus Gastrointestinal Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      149
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      152
      num Events
      1
    term
    Device Related Sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      149
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      152
      num Events
      2
    term
    Diverticulitis
time Frame
AE data was collected from the time of first dose of study drug administration up to 30 days following the last administration of study treatment (maximum duration up to 306.6 weeks for Pd arm and 311.0 weeks for IPd arm). Per participant, the deaths were collected up to a maximum duration of approximately 72.38 months.

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Preserved source evidence · Not medical advice