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NCT02613182 · ADVERSE EVENTS

Adverse events

Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis · Source last updated 2019-05-16

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 the last study visit or up to 30 days after date of last dose
Other-event reporting threshold
5%

AE that newly appears, increases in frequency, or worsens in severity following initiation of study

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

24 mg/kg IV every 28 days for 22 months

12 / 3434 / 346 / 34

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
    notes
    Respiratory syncytial virus infection
    organ System
    Infections and infestations
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Lung Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Respiratory syncytial virus infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Skin infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Urinary tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Cardiac failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Fall
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Lower limb fracture
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Hypervolaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Hyponatraemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    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
    MedDRA 19.0 (Hierarc
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      34
    term
    Upper respiratory tract infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Urinary tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      34
    term
    Oedema peripheral
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      34
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Chest discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      34
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      34
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      34
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      34
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Abdominal distension
Complete source fields
description
AE that newly appears, increases in frequency, or worsens in severity following initiation of study
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    34
    description
    24 mg/kg IV every 28 days for 22 months
    id
    EG000
    other Num Affected
    34
    other Num At Risk
    34
    serious Num Affected
    12
    serious Num At Risk
    34
    title
    NEOD001 24 mg/kg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19.0 (Hierarc
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      34
    term
    Upper respiratory tract infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Urinary tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      34
    term
    Oedema peripheral
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      34
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Chest discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      34
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      34
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      34
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      34
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Abdominal distension
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Respiratory syncytial virus infection
    organ System
    Infections and infestations
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Lung Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Respiratory syncytial virus infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Skin infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Urinary tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Cardiac failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Fall
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Lower limb fracture
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Hypervolaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Hyponatraemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MeDRA 19.0 Hierarchy
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Cerebrovascular accident
time Frame
Initiation of study drug through the last study visit or up to 30 days after date of last dose

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Preserved source evidence · Not medical advice