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NCT04798586 · ADVERSE EVENTS

Adverse events

MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma · Source last updated 2024-09-27

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
From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment)
Other-event reporting threshold
0%

Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality: the total number of deaths during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 90 days post last dose of study intervention.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Elranatamab

Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks).

3 / 44 / 42 / 4

Group identifiers: EG000: Elranatamab

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
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    term
    Death
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    term
    Malaise
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    term
    Pneumonia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    term
    Sepsis

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 v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    term
    Vertigo
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    term
    Injection site reaction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    term
    Pyrexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      4
    term
    Cytokine release syndrome
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    term
    Hypogammaglobulinaemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    term
    Bronchitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    term
    Conjunctivitis
Complete source fields
description
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality: the total number of deaths during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 90 days post last dose of study intervention.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks).
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Elranatamab
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    term
    Vertigo
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    term
    Injection site reaction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    term
    Pyrexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      4
    term
    Cytokine release syndrome
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    term
    Hypogammaglobulinaemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    term
    Bronchitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    term
    Conjunctivitis
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    term
    Death
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    term
    Malaise
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    term
    Pneumonia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    term
    Sepsis
time Frame
From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment)

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Preserved source evidence · Not medical advice