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NCT05347485 · ADVERSE EVENTS

Adverse events

A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma · Source last updated 2025-04-25

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
All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100
Other-event reporting threshold
5%

All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)

Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\*10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.

42 / 8281 / 8216 / 82

Group identifiers: EG000: Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)

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 Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    term
    Cardiac Arrest
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    term
    Adrenal Insufficiency
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      82
    term
    Multiple Organ Dysfunction Syndrome
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      82
    term
    Pyrexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      82
    term
    Cytokine Release Syndrome
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    term
    Adenovirus Infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    term
    Clostridium Difficile Colitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      82
    term
    Covid-19

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 Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      82
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      82
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      82
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      82
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      82
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      82
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      82
    term
    Atrial Fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      82
    term
    Sinus Bradycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      82
    term
    Sinus Tachycardia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      82
    term
    Dry Eye
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      82
    term
    Vision Blurred
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      82
    term
    Abdominal Pain
Complete source fields
description
All-treated analysis set which included all participants who received study intervention (cilta-cel out-of-specifications \[OOS\]).
event Groups
  1. deaths Num Affected
    16
    deaths Num At Risk
    82
    description
    Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\*10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
    id
    EG000
    other Num Affected
    81
    other Num At Risk
    82
    serious Num Affected
    42
    serious Num At Risk
    82
    title
    Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      82
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      82
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      82
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      82
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      82
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      82
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      82
    term
    Atrial Fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      82
    term
    Sinus Bradycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      82
    term
    Sinus Tachycardia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      82
    term
    Dry Eye
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      82
    term
    Vision Blurred
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      82
    term
    Abdominal Pain
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    term
    Cardiac Arrest
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    term
    Adrenal Insufficiency
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      82
    term
    Multiple Organ Dysfunction Syndrome
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      82
    term
    Pyrexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      82
    term
    Cytokine Release Syndrome
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    term
    Adenovirus Infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      82
    term
    Clostridium Difficile Colitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      82
    term
    Covid-19
time Frame
All-cause Mortality: From Day 1 (post infusion) up to 18.6 months; Serious and Other AEs: From Day 1 (post infusion) up to Day 100

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