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NCT03568461 · ADVERSE EVENTS

Adverse events

Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma · Source last updated 2026-07-09

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
Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 60 months for each patient. All-cause mortality was assessed from day of infusion up to 65.8 months.
Other-event reporting threshold
5%

AE Description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
CTL019

All participants who were enrolled in the study

52 / 9795 / 9722 / 97

Group identifiers: EG000: CTL019

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 (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      97
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      97
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Ventricular fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Blindness
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Gastrointestinal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Gastrointestinal ulcer
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Glossitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Nausea

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 (28.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      97
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      97
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      97
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      97
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      97
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      97
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      97
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      97
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      97
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      97
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      97
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      97
    term
    Asthenia
Complete source fields
description
AE Description: Any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study).
event Groups
  1. deaths Num Affected
    22
    deaths Num At Risk
    97
    description
    All participants who were enrolled in the study
    id
    EG000
    other Num Affected
    95
    other Num At Risk
    97
    serious Num Affected
    52
    serious Num At Risk
    97
    title
    CTL019
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      97
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      97
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      97
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      97
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      97
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      97
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      97
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      97
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      97
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      97
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      97
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      97
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      97
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      97
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Ventricular fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Blindness
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Gastrointestinal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Gastrointestinal ulcer
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Glossitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (28.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      97
    term
    Nausea
time Frame
Adverse events were collected during the post-infusion period (starting at the day of infusion until the end of the study), up to maximum duration of 60 months for each patient. All-cause mortality was assessed from day of infusion up to 65.8 months.

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