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NCT02445248 · ADVERSE EVENTS

Adverse events

Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients · Source last updated 2024-04-18

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 (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).
Other-event reporting threshold
5%

AE is 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) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Tisagenlecleucel - All Patients

Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.

84 / 115113 / 11576 / 115

Group identifiers: EG000: Tisagenlecleucel - All Patients

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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      115
    term
    Bone marrow failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      115
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      115
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      115
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      115
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      115
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      115
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      115
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      115
    term
    Cardio-respiratory arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      115
    term
    Cardiopulmonary failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      115
    term
    Vertigo
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      115
    term
    Abdominal pain

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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      115
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      115
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      115
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      115
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      115
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      115
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      115
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      115
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      115
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      115
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      115
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      115
    term
    Vomiting
Complete source fields
description
AE is 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) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse Adverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.
event Groups
  1. deaths Num Affected
    76
    deaths Num At Risk
    115
    description
    Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
    id
    EG000
    other Num Affected
    113
    other Num At Risk
    115
    serious Num Affected
    84
    serious Num At Risk
    115
    title
    Tisagenlecleucel - All Patients
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      115
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      115
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      115
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      115
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      115
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      115
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      115
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      115
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      115
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      115
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      115
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      115
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      115
    term
    Bone marrow failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      115
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      115
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      115
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      115
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      115
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      115
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      115
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      115
    term
    Cardio-respiratory arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      115
    term
    Cardiopulmonary failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      115
    term
    Vertigo
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      115
    term
    Abdominal pain
time Frame
Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV).

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