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NCT01484275 · ADVERSE EVENTS

Adverse events

A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma · Source last updated 2020-01-27

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
Up to 4.7 Years
Other-event reporting threshold
5%

Safety analysis set included participants who have received at least 1 administration of any study agent (siltuximab or placebo).

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

Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).

13 / 4341 / 433 / 43
Placebo

Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).

13 / 4242 / 424 / 42

Group identifiers: EG000: Siltuximab · EG001: Placebo

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 Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Acute Coronary Syndrome
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Cardiac Arrest
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Eustachian Tube Disorder
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Gastric Disorder
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Asthenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Cholecystitis Acute
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Diverticulitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Influenza
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Lower Respiratory Tract Infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Mastoiditis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Otitis Media

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 Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Palpitations
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Abdominal Distension
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      42
    term
    Abdominal Pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Abdominal Pain Lower
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Abdominal Pain Upper
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      42
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      42
    term
    Diarrhoea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      42
    term
    Nausea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Stomatitis
Complete source fields
description
Safety analysis set included participants who have received at least 1 administration of any study agent (siltuximab or placebo).
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    43
    description
    Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
    id
    EG000
    other Num Affected
    41
    other Num At Risk
    43
    serious Num Affected
    13
    serious Num At Risk
    43
    title
    Siltuximab
  2. deaths Num Affected
    4
    deaths Num At Risk
    42
    description
    Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).
    id
    EG001
    other Num Affected
    42
    other Num At Risk
    42
    serious Num Affected
    13
    serious Num At Risk
    42
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Palpitations
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Abdominal Distension
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      42
    term
    Abdominal Pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Abdominal Pain Lower
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      42
    term
    Abdominal Pain Upper
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      42
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      42
    term
    Diarrhoea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      42
    term
    Nausea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Stomatitis
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Acute Coronary Syndrome
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Cardiac Arrest
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Eustachian Tube Disorder
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Gastric Disorder
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Asthenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Cholecystitis Acute
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Diverticulitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Influenza
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Lower Respiratory Tract Infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Mastoiditis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Otitis Media
time Frame
Up to 4.7 Years

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