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NCT03589469 · ADVERSE EVENTS

Adverse events

Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma · Source last updated 2023-08-29

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 43 months
Other-event reporting threshold
5%

All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.

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

Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.

57 / 145139 / 14597 / 145

Group identifiers: EG000: Loncastuximab Tesirine

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 (22.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      145
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      145
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      145
    term
    Pericardial effusion
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
    term
    Pericarditis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      145
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
    term
    Ascites
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
    term
    Dysphagia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
    term
    Intestinal obstruction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
    term
    Small intestinal obstruction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
    term
    Small intestinal perforation

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 (22.0)
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      145
    term
    Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      145
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      145
    term
    Anaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      145
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      145
    term
    Lymphopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      145
    term
    Tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      145
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      145
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      145
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      145
    term
    Constipation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      145
    term
    Abdominal pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      145
    term
    Fatigue
Complete source fields
description
All non-serious AEs at a frequency threshold of \>=5% and all SAEs, regardless of relationship to study drug, were reported from the time the participant signs the ICF until 30 days after the last dose of study drug or start of new anti-cancer therapy, whichever is earlier; thereafter, only related SAEs were collected, with two exceptions of participants with subsequent SCT or CAR-T therapy.
event Groups
  1. deaths Num Affected
    97
    deaths Num At Risk
    145
    description
    Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
    id
    EG000
    other Num Affected
    139
    other Num At Risk
    145
    serious Num Affected
    57
    serious Num At Risk
    145
    title
    Loncastuximab Tesirine
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      145
    term
    Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      145
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      145
    term
    Anaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      145
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      145
    term
    Lymphopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      145
    term
    Tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      145
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      145
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      145
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      145
    term
    Constipation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      145
    term
    Abdominal pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      145
    term
    Fatigue
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      145
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      145
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      145
    term
    Pericardial effusion
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
    term
    Pericarditis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      145
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
    term
    Ascites
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
    term
    Dysphagia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
    term
    Intestinal obstruction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
    term
    Small intestinal obstruction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      145
    term
    Small intestinal perforation
time Frame
Up to 43 months

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Preserved source evidence · Not medical advice