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NCT03154047 · ADVERSE EVENTS

Adverse events

Study in Subjects With Light Chain (AL) Amyloidosis · Source last updated 2019-03-26

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
Initiation of study drug through study completion, up to 11 months
Other-event reporting threshold
5%

AE that newly appears, increases in frequency, or worsens in severity following initiation of study drug and through the last study visit or up to 30 days after date of last dose, whichever is later.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
NEOD001 24 mg/kg

NEOD001, 24 mg/kg IV every 4 weeks for 36 months

13 / 8028 / 801 / 80

Group identifiers: EG000: NEOD001 24 mg/kg

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
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Device related infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Endocarditis bacterial
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Influenza
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Lung Infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Septic embolus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Fluid overload
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Hyponatraemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
    term
    Cerebrovascular accident

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
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      80
    term
    Upper respiratory tract infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      80
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
    term
    Oedema peripheral
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
    term
    Arthralgia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      80
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      80
    term
    Headache
Complete source fields
description
AE that newly appears, increases in frequency, or worsens in severity following initiation of study drug and through the last study visit or up to 30 days after date of last dose, whichever is later.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    80
    description
    NEOD001, 24 mg/kg IV every 4 weeks for 36 months
    id
    EG000
    other Num Affected
    28
    other Num At Risk
    80
    serious Num Affected
    13
    serious Num At Risk
    80
    title
    NEOD001 24 mg/kg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      80
    term
    Upper respiratory tract infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      80
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
    term
    Oedema peripheral
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
    term
    Arthralgia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      80
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      80
    term
    Headache
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Device related infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Endocarditis bacterial
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Influenza
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Lung Infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Septic embolus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Fluid overload
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Hyponatraemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
    term
    Cerebrovascular accident
time Frame
Initiation of study drug through study completion, up to 11 months

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Preserved source evidence · Not medical advice