Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02632786 · ADVERSE EVENTS

Adverse events

The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis · Source last updated 2019-04-05

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, whichever is later
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

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

24 mg/kg IV every 4 weeks for 12 months

14 / 6658 / 663 / 66
Placebo

0.9% Saline IV every 4 weeks for 12 months

15 / 6352 / 636 / 63

Group identifiers: EG000: NEOD001 24 mg/kg · 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
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      63
    term
    Cardiac failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
    term
    Bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
    term
    Atrioventricular block complete
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
    term
    Cardiac failure acute
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
    term
    Cardiac failure congestive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
    term
    Pericardial effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      63
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
    term
    Cellulitis

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)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      63
    term
    Upper respiratory tract infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      63
    term
    Nasopharyngitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      63
    term
    Urinary tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      63
    term
    Respiratory tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      63
    term
    Bronchitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      63
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      63
    term
    Oedema peripheral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      63
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      63
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      63
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      63
    term
    Constipation
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
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    66
    description
    24 mg/kg IV every 4 weeks for 12 months
    id
    EG000
    other Num Affected
    58
    other Num At Risk
    66
    serious Num Affected
    14
    serious Num At Risk
    66
    title
    NEOD001 24 mg/kg
  2. deaths Num Affected
    6
    deaths Num At Risk
    63
    description
    0.9% Saline IV every 4 weeks for 12 months
    id
    EG001
    other Num Affected
    52
    other Num At Risk
    63
    serious Num Affected
    15
    serious Num At Risk
    63
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      63
    term
    Upper respiratory tract infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      63
    term
    Nasopharyngitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      63
    term
    Urinary tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      63
    term
    Respiratory tract infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      63
    term
    Bronchitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      63
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      63
    term
    Oedema peripheral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      63
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      63
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      63
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      63
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      63
    term
    Cardiac failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
    term
    Bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
    term
    Atrioventricular block complete
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
    term
    Cardiac failure acute
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
    term
    Cardiac failure congestive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      63
    term
    Pericardial effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      63
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      63
    term
    Cellulitis
time Frame
Initiation of study drug through the last study visit or up to 30 days after date of last dose, whichever is later

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice