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NCT02435849 · ADVERSE EVENTS

Adverse events

Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients · Source last updated 2024-02-13

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 Event (AE) timeframe: 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 60 months for each patient. Deaths were collected at all points post-treatment (including post-treatment survival follow-up period) until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-treatment survival follow-up deaths.
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) and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Main Cohort (On-treatment + Post-treatment Survival Follow-up Deaths)

Single dose of CTL019Edit Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).

63 / 7979 / 7933 / 79
Cohort 1 (On-treatment + Post-treatment Survival Follow-up Deaths)

Single dose of CTL019Edit Pediatric B-ALL patients who are very high risk at first relapse.

0 / 11 / 10 / 1

Group identifiers: EG000: Main Cohort (On-treatment + Post-treatment Survival Follow-up Deaths) · EG001: Cohort 1 (On-treatment + Post-treatment Survival Follow-up Deaths)

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
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Coagulopathy
  2. 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
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Disseminated intravascular coagulation
  3. 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
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Febrile 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
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Pancytopenia
  5. 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
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Thrombocytopenia
  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
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Atrioventricular block first degree
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Cardiac failure
  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
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Left ventricular dysfunction
  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
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Abdominal compartment syndrome
  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
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Constipation

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
      25
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    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
      5
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Febrile 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
      11
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    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
      8
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Mouth haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Vomiting
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) and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table.
event Groups
  1. deaths Num Affected
    33
    deaths Num At Risk
    79
    description
    Single dose of CTL019Edit Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).
    id
    EG000
    other Num Affected
    79
    other Num At Risk
    79
    serious Num Affected
    63
    serious Num At Risk
    79
    title
    Main Cohort (On-treatment + Post-treatment Survival Follow-up Deaths)
  2. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Single dose of CTL019Edit Pediatric B-ALL patients who are very high risk at first relapse.
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Cohort 1 (On-treatment + Post-treatment Survival Follow-up Deaths)
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
      25
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    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
      5
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Febrile 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
      11
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    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
      8
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Mouth haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    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
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Coagulopathy
  2. 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
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Disseminated intravascular coagulation
  3. 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
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Febrile 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
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Pancytopenia
  5. 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
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Thrombocytopenia
  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
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Atrioventricular block first degree
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Cardiac failure
  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
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Left ventricular dysfunction
  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
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Abdominal compartment syndrome
  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
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Constipation
time Frame
Adverse Event (AE) timeframe: 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 60 months for each patient. Deaths were collected at all points post-treatment (including post-treatment survival follow-up period) until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-treatment survival follow-up deaths.

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