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NCT01829711 · ADVERSE EVENTS

Adverse events

Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia · Source last updated 2020-04-08

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
For TEAEs and TESAEs: From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months) All-cause mortality data: From the start of study treatment (Day 1) through end of study (approximately 6 years)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Moxetumomab Pasudotox 40 µg/kg

Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.

28 / 8077 / 804 / 80

Group identifiers: EG000: Moxetumomab Pasudotox 40 µg/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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
      num Events
      3
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      80
      num Events
      6
    term
    Haemolytic uraemic syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    term
    Left ventricular dysfunction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    term
    Neutropenic colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    term
    Multiple organ dysfunction syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    term
    Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      80
      num Events
      5
    term
    Pyrexia
  12. 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
      80
      num Events
      1
    term
    Clostridium difficile colitis

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      80
      num Events
      41
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
      num Events
      5
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      80
      num Events
      6
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
      num Events
      4
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      80
      num Events
      6
    term
    Dry eye
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      80
      num Events
      8
    term
    Vision blurred
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      80
      num Events
      12
    term
    Abdominal distension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      80
      num Events
      7
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
      num Events
      5
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      80
      num Events
      21
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      80
      num Events
      20
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
      num Events
      5
    term
    Dyspepsia
Complete source fields
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    80
    description
    Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.
    id
    EG000
    other Num Affected
    77
    other Num At Risk
    80
    serious Num Affected
    28
    serious Num At Risk
    80
    title
    Moxetumomab Pasudotox 40 µg/kg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      80
      num Events
      41
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
      num Events
      5
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      80
      num Events
      6
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
      num Events
      4
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      80
      num Events
      6
    term
    Dry eye
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      80
      num Events
      8
    term
    Vision blurred
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      80
      num Events
      12
    term
    Abdominal distension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      80
      num Events
      7
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
      num Events
      5
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      80
      num Events
      21
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      80
      num Events
      20
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
      num Events
      5
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
      num Events
      3
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      80
      num Events
      6
    term
    Haemolytic uraemic syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    term
    Left ventricular dysfunction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    term
    Neutropenic colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    term
    Multiple organ dysfunction syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    term
    Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      80
      num Events
      5
    term
    Pyrexia
  12. 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
      80
      num Events
      1
    term
    Clostridium difficile colitis
time Frame
For TEAEs and TESAEs: From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months) All-cause mortality data: From the start of study treatment (Day 1) through end of study (approximately 6 years)

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